TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01019928

Adverse event: Feeling cold
Serious: no
Organ System: General disorders
Frequency: 7 affected / 13 at risk

Adverse event: Chills
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Feeling of body temperature change
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypoaesthesia oral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 13 at risk

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

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

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

Adverse event: Body temperature increased
Serious: no
Organ System: Investigations
Frequency: 4 affected / 13 at risk

Adverse event: Ageusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 13 at risk

Adverse event: Arthropod sting
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

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

Adverse event: Peripheral coldness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: ECG, atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT01020435

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 24 at risk

Adverse event: Migraine
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Headache and tenderness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Neck and back pain and fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 24 at risk

Adverse event: Hypotension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 24 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 27 at risk

Adverse event: Radiating symptoms
Serious: no
Organ System: General disorders
Frequency: 2 affected / 27 at risk

Adverse event: Dizziness/imbalance/vertigo
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk

Adverse event: Hypertension
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk
Study: NCT01020526

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 63 at risk

Adverse event: Joint instability
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 63 at risk

Adverse event: Migraine
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 63 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 63 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 63 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 63 at risk

Adverse event: Ear infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 63 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 14 affected / 63 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 63 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Notes: The number of females is 53 out of 63 participants and dysmenorrhoea occurs in females only thus exceeds 5%.
Frequency: 3 affected / 53 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 63 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 63 at risk
Study: NCT01020747

Adverse event: Aguesia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: cough/URI
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: disk herniation
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Diminished voice volume
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: drainage and congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 20 at risk

Adverse event: eye twitching
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 20 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

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

Adverse event: higher pitch
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 20 affected / 20 at risk

Adverse event: Sedation complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 20 at risk

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

Adverse event: toe (right) cellulitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: tongue numbness
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 20 at risk

Adverse event: Toothache
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk
Study: NCT01020799

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 96 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 5 affected / 96 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 96 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 96 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 96 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 96 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 96 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 96 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 99 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 99 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 99 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 99 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 99 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 99 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 99 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 99 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 99 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 50 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 50 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 50 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 50 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 50 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 50 at risk

Adverse event: Libido decreased
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 50 at risk
Study: NCT01020812

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Grade 2 fatigue
Frequency: 2 affected / 8 at risk

Adverse event: Hepatobiliary disorder
Serious: no
Organ System: Hepatobiliary disorders
Notes: 2 events, 1 event of grade 3 and 1 event of grade 2 liver toxicity
Frequency: 1 affected / 8 at risk

Adverse event: transiminitis
Serious: no
Organ System: Hepatobiliary disorders
Notes: 2 events of grade 1
Frequency: 1 affected / 8 at risk

Adverse event: Large intestinal ulcer
Serious: no
Organ System: Gastrointestinal disorders
Notes: Grade 2
Frequency: 1 affected / 8 at risk

Adverse event: bili increase
Serious: no
Organ System: Hepatobiliary disorders
Notes: 2 events of grade 2
Frequency: 1 affected / 8 at risk
Study: NCT01020877

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 6 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Blood urine present
Serious: no
Organ System: General disorders
Frequency: 1 affected / 38 at risk

Adverse event: Abdominal Pain/Cramps
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 8 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Blood urine present
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Protein in Urine
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk
Study: NCT01021007

Adverse event: discomfort in mouth or body
Serious: no
Organ System: Social circumstances
Notes: 1 panelist reported discomfort from a popcorn kernel stuck between teeth. 7 panelists reported discomfort in ranging from a tooth ache to muscle pains. All unrelated to study product use and went away with no lingering effects to the panelist.
Frequency: 8 affected / 34 at risk

Adverse event: Tooth staining
Serious: no
Organ System: General disorders
Notes: Panelist reports the appearence of yellow to brown staining of their teeth. All staining was removed after a dental cleaning. No lingering effects to the panelist.
Frequency: 1 affected / 34 at risk

Adverse event: slight swelling or inflammation of the gums
Serious: no
Organ System: General disorders
Notes: panelists reported slight iritation or tenderness or swelling or inflammation of the tongue or gums. All chages reported to the panelists oral health were resolved during the study and no lingering effects were noted.
Frequency: 3 affected / 34 at risk

Adverse event: Tooth staining
Serious: no
Organ System: General disorders
Notes: Panelist reports the appearence of yellow to brown staining of their teeth. All staining was removed after a dental cleaning. No lingering effects to the panelist.
Frequency: 7 affected / 33 at risk

Adverse event: slight swelling or inflammation of the gums
Serious: no
Organ System: General disorders
Notes: panelists reported slight iritation or tenderness or swelling or inflammation of the tongue or gums. All chages reported to the panelists oral health were resolved during the study and no lingering effects were noted.
Frequency: 2 affected / 33 at risk
Study: NCT01021020

Adverse event: Paraesthesia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 26 at risk

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

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

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

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

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 27 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Cold sweat
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: 2 affected / 27 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 27 at risk
Study: NCT01021553

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 25 at risk

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

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Testicular pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 25 at risk

Adverse event: Blood bilirubin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 25 at risk

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

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 22 at risk

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

Adverse event: Blepharospasm
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 22 at risk

Adverse event: Procedural pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 22 at risk

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 22 at risk

Adverse event: Tooth extraction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 28 at risk

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

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

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 28 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 28 at risk

Adverse event: Genital discomfort
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 28 at risk
Study: NCT01021618

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Hypotension
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 44 at risk

Adverse event: Severe Flushing
Serious: no
Organ System: General disorders
Frequency: 2 affected / 44 at risk

Adverse event: Severe Shortness of Breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 44 at risk

Adverse event: Severe Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 44 at risk

Adverse event: Severe Chest Discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 7 affected / 44 at risk

Adverse event: Severe Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 44 at risk

Adverse event: Severe Abdominal Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 44 at risk

Adverse event: Bronchospasm
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 96 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 96 at risk

Adverse event: Severe Flushing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 94 at risk

Adverse event: Severe Shortness of Breath
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 94 at risk

Adverse event: Severe Chest Discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 94 at risk

Adverse event: Severe Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 94 at risk

Adverse event: Severe Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 94 at risk

Adverse event: Severe Abdominal Pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 94 at risk
Study: NCT01021852

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 12 affected / 315 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 315 at risk

Adverse event: Periorbital cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 79 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 79 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 79 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 78 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 78 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 80 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 80 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 81 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 81 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 315 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 315 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 315 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 324 at risk
Study: NCT01021878

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Notes: Peritonitis related to Peritoneal dialysis
Frequency: 2 affected / 33 at risk

Adverse event: Exit-site infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 33 at risk

Adverse event: Hernia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 33 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 33 at risk

Adverse event: Death
Serious: yes
Organ System: Infections and infestations
Notes: Sepsis
Frequency: 1 affected / 27 at risk

Adverse event: Peritonitis
Serious: yes
Organ System: Infections and infestations
Notes: Peritonitis related to Peritoneal dialysis
Frequency: 2 affected / 27 at risk

Adverse event: Exit-site infection
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 27 at risk

Adverse event: Ultrafiltration failure
Serious: no
Organ System: General disorders
Frequency: 1 affected / 27 at risk