TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01774253

Adverse event: Choking event resulting in death
Serious: yes
Organ System: General disorders
Notes: Subject choked on a hot dog resulting in death. Unrelated to study.
Frequency: 1 affected / 9 at risk

Adverse event: Alopecia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Ataxia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 9 at risk

Adverse event: Gastoesophageal Reflux Disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk

Adverse event: Increased GGT
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 9 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 9 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 9 at risk
Study: NCT01774305

Adverse event: prolonged intubation
Serious: no
Organ System: Surgical and medical procedures
Notes: 1 patient in Dex group was intubated more than 3 hrs due to changed surgical plan.
Frequency: 1 affected / 71 at risk
Study: NCT01774487

Adverse event: Failure to thrive
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospital admission for nutrition optimization (expected with biliary atresia)
Frequency: 3 affected / 8 at risk

Adverse event: Cholangitis
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hospital admission for cholangitis (expected with biliary atresia)
Frequency: 2 affected / 8 at risk

Adverse event: Bile leak
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hospital admission for bile leak (can happen with biliary atresia)
Frequency: 1 affected / 8 at risk

Adverse event: ALT >2.5X baseline
Serious: no
Organ System: Hepatobiliary disorders
Notes: ALT levels 2.5X above level at Kasai portoenterostomy
Frequency: 1 affected / 8 at risk

Adverse event: Platelets <150,000/ul
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia (sign of portal hypertension)
Frequency: 3 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting from feeds and/or mediations, requiring change in feeding or medication regimen
Frequency: 2 affected / 8 at risk

Adverse event: Stopped medication before 12 week period
Serious: no
Organ System: Product Issues
Notes: Stopped medication before the study end period because of vomiting
Frequency: 2 affected / 8 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospital admission for nutrition optimization (expected with biliary atresia)
Frequency: 1 affected / 1 at risk

Adverse event: Ascites
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Hospital admission for ascites management (expected with biliary atresia)
Frequency: 1 affected / 1 at risk

Adverse event: Platelets <150,000/ul
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Thrombocytopenia (sign of portal hypertension)
Frequency: 1 affected / 1 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Vomiting from feeds and/or mediations, requiring change in feeding or medication regimen
Frequency: 1 affected / 1 at risk
Study: NCT01774591

Adverse event: Hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 10 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertension
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 10 at risk
Study: NCT01774604

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients with any type of gastrointestinal bleeding
Frequency: 4 affected / 223 at risk

Adverse event: Severe Acute Pancreatitis Leading to Death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 226 at risk

Adverse event: Secondary Bacterial Peritonitis due to Multifocal Hepatocellular Carcinoma Leading to Death
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 226 at risk

Adverse event: Aspiration Post-Procedure Leading to Death
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 226 at risk

Adverse event: Gastrointestinal haemorrhage
Serious: no
Organ System: Gastrointestinal disorders
Notes: Patients with any type of gastrointestinal bleeding
Frequency: 6 affected / 226 at risk
Study: NCT01774903

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Vertigo
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 45 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 45 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 45 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 45 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 17 affected / 45 at risk

Adverse event: Bitter taste
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 45 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 45 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 45 at risk

Adverse event: Loss of appetizer
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 45 at risk

Adverse event: Palpitations
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 45 at risk

Adverse event: Irritate
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 45 at risk
Study: NCT01774929

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 2 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 7 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: General disorders
Frequency: 5 affected / 35 at risk

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

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

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Frequency: 7 affected / 35 at risk

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

Adverse event: Pruritus
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

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

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

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

Adverse event: Vertigo
Serious: no
Organ System: General disorders
Frequency: 3 affected / 35 at risk

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

Adverse event: Dysphonia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk
Study: NCT01775371

Adverse event: Hypotension
Serious: no
Organ System: Cardiac disorders
Notes: Systolic blood pressure \< 90 mm Hg.
Frequency: 4 affected / 306 at risk

Adverse event: Oxygen desaturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen saturation \<92%
Frequency: 3 affected / 306 at risk

Adverse event: Oxygen desaturation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Oxygen saturation \<92%
Frequency: 1 affected / 330 at risk
Study: NCT01775410

Adverse event: Dissection
Serious: yes
Organ System: Vascular disorders
Notes: Dissection of the vessel wall
Frequency: 2 affected / 4 at risk
Study: NCT01775774

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Infarcts of kidneys, spleen and brain
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 3 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk

Adverse event: Elevated liver function tests
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 3 at risk

Adverse event: Pulmonary embolism
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 3 at risk
Study: NCT01775787

Adverse event: Family Emergency
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 13 at risk

Adverse event: Thoat itchy and cough
Serious: no
Organ System: General disorders
Notes: HEENT ( head, ears, eyes, nose and throat)
Frequency: 1 affected / 14 at risk

Adverse event: Concerns with using IV
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 14 at risk

Adverse event: Time Commitment
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 14 at risk

Adverse event: Family Emergency
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 14 at risk

Adverse event: Concerns with using IV
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 8 at risk

Adverse event: Time Commitment
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 8 at risk
Study: NCT01775813

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 20 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 24 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 24 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 24 at risk
Study: NCT01775865

Adverse event: Elevated AST/ALT
Serious: no
Organ System: Hepatobiliary disorders
Notes: Elevated serum AST/ALT after 2 weeks of salsalate that resolved within 7 days after stopping medications without complication
Frequency: 1 affected / 14 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Eye disorders
Notes: One participant in placebo group developed allergic reaction (facial / orbital swelling) but after withdrawl from study and PI unblinded it was determined that the participant was in the placebo group. Follow up likley allergy to shellfish.
Frequency: 1 affected / 14 at risk
Study: NCT01775995

Adverse event: Increased cigarette smoking
Serious: no
Organ System: General disorders
Notes: One participant reported increased cigarette smoking during the meditation course (course started on 3-25-13), however, prior to the end of the course this individual reported they were able to quit smoking altogether (on 5-1-13).
Frequency: 1 affected / 21 at risk

Adverse event: Weight increased
Serious: no
Organ System: General disorders
Notes: One participant reported an increase in weight during the meditation course (course started on 3-25-13), however after the end of the course the participant reported their weight decreased again (on 5-21-13).
Frequency: 1 affected / 21 at risk

Adverse event: Increased pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Two participants reported increased pain with mindful movement or when learning to mindfully 'observe' pain experiences, during the meditation course (course started on 3-25-13 and ended on 5-13-13).
Frequency: 2 affected / 21 at risk

Adverse event: Anxiety/Emotional Distress
Serious: no
Organ System: General disorders
Notes: Three participants reported increased anxiety or emotional distress while learning the meditation intervention techniques during the course (course started on 3-25-13 and ended on 5-13-13).
Frequency: 3 affected / 21 at risk
Study: NCT01776268

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 48 at risk
Study: NCT01776632

Adverse event: Ankle fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Study participant fell and broke ankle during walking group
Frequency: 1 affected / 217 at risk
Study: NCT01777126

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 48 at risk

Adverse event: Fistula or leak
Serious: no
Organ System: General disorders
Frequency: 1 affected / 48 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 5 affected / 48 at risk

Adverse event: DGE/Nausea&vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 48 at risk

Adverse event: Cardiopulmonary
Serious: no
Organ System: Cardiac disorders
Frequency: 11 affected / 48 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 48 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 13 affected / 48 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 46 at risk

Adverse event: Fistula or leak
Serious: no
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: General disorders
Frequency: 2 affected / 46 at risk

Adverse event: DGE/Nausea&vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 46 at risk

Adverse event: Cardiopulmonary
Serious: no
Organ System: Cardiac disorders
Frequency: 4 affected / 46 at risk

Adverse event: Neurologic
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 46 at risk

Adverse event: Other
Serious: no
Organ System: General disorders
Frequency: 11 affected / 46 at risk
Study: NCT01777139

Adverse event: Diabetic retinopathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Vitreous haemorrhage
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 30 at risk

Adverse event: Endophthalmitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 30 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 30 at risk

Adverse event: Postictal state
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 30 at risk

Adverse event: Retinal pigmentation
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 30 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 30 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 3 affected / 30 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 30 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 30 at risk

Adverse event: Memory impairment
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 30 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 30 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 30 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 30 at risk

Adverse event: Rash macular
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 30 at risk
Study: NCT01777191

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 102 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 8 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 102 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 102 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 102 at risk

Adverse event: Tooth abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 102 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 102 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 5 affected / 102 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 102 at risk

Adverse event: Cardio-respiratory arrest
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Supraventricular tachycardia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 185 at risk

Adverse event: Colitis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Gastric ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 185 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Diverticulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 185 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 185 at risk

Adverse event: Injection site reaction
Serious: no
Organ System: General disorders
Frequency: 8 affected / 185 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 185 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 176 at risk
Study: NCT01777295

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 38 at risk

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

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 38 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 38 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Cholecystitis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dysmenorrhoea
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 3 affected / 40 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 40 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 40 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 40 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 40 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Toothache
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 40 at risk
Study: NCT01777308

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 56 affected / 119 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 31 affected / 119 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 119 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 30 affected / 119 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 69 affected / 119 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 119 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 30 affected / 119 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 119 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 19 affected / 37 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 37 at risk

Adverse event: Gastrointestinal disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 37 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 15 affected / 37 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 37 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Frequency: 8 affected / 37 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 37 at risk