TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT03049852

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 24 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Notes: Mild eye irritation
Frequency: 3 affected / 24 at risk

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: not treatment related
Frequency: 1 affected / 25 at risk

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

Adverse event: Conjunctival discolouration
Serious: no
Organ System: Eye disorders
Frequency: 14 affected / 26 at risk

Adverse event: Foreign body sensation in eyes
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 26 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: General disorders
Frequency: 2 affected / 26 at risk
Study: NCT03049969

Adverse event: Paraesthesia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 15 at risk

Adverse event: Itching Sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 15 at risk

Adverse event: Warmth Sensation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 14 affected / 15 at risk
Study: NCT03050307

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 115 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 115 at risk

Adverse event: Pepsinogen test positive
Serious: no
Organ System: Investigations
Frequency: 29 affected / 115 at risk

Adverse event: Pepsinogen I increased
Serious: no
Organ System: Investigations
Frequency: 23 affected / 115 at risk

Adverse event: Blood gastrin increased
Serious: no
Organ System: Investigations
Frequency: 24 affected / 115 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 6 affected / 115 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 115 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 119 at risk

Adverse event: Liver abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 119 at risk

Adverse event: Pepsinogen test positive
Serious: no
Organ System: Investigations
Frequency: 6 affected / 119 at risk

Adverse event: Pepsinogen I increased
Serious: no
Organ System: Investigations
Frequency: 8 affected / 119 at risk

Adverse event: Blood gastrin increased
Serious: no
Organ System: Investigations
Frequency: 5 affected / 119 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 119 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 119 at risk
Study: NCT03050359

Adverse event: Duodenal ulcer haemorrhage
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 263 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 21 affected / 263 at risk

Adverse event: Pepsinogen test positive
Serious: no
Organ System: Investigations
Frequency: 124 affected / 263 at risk

Adverse event: Pepsinogen I increased
Serious: no
Organ System: Investigations
Frequency: 92 affected / 263 at risk

Adverse event: Blood gastrin increased
Serious: no
Organ System: Investigations
Frequency: 97 affected / 263 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 20 affected / 263 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 12 affected / 263 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 21 affected / 263 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 268 at risk

Adverse event: Bladder transitional cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 268 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 268 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 37 affected / 268 at risk

Adverse event: Pepsinogen test positive
Serious: no
Organ System: Investigations
Frequency: 28 affected / 268 at risk

Adverse event: Pepsinogen I increased
Serious: no
Organ System: Investigations
Frequency: 37 affected / 268 at risk

Adverse event: Blood gastrin increased
Serious: no
Organ System: Investigations
Frequency: 20 affected / 268 at risk

Adverse event: Protein urine present
Serious: no
Organ System: Investigations
Frequency: 11 affected / 268 at risk

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 17 affected / 268 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 22 affected / 268 at risk
Study: NCT03050450

Adverse event: Hospitalized for ascites
Serious: yes
Organ System: Gastrointestinal disorders
Notes: This Serious Adverse Event (SAE) was related to disease - the patient hospitalized for ascites and found to have peritoneal seeding via ventriculoperitoneal shunt
Frequency: 1 affected / 6 at risk

Adverse event: Hospitalized for abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient with G-tube hospitalized for abdominal pain and observed and discharged.
Frequency: 1 affected / 6 at risk

Adverse event: Grade 3-4
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk
Study: NCT03050489

Adverse event: Low cardiac output synfrome
Serious: yes
Organ System: Cardiac disorders
Notes: Low cardiac output synfrome when cardiac index \<2.2
Frequency: 15 affected / 128 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 128 at risk

Adverse event: Low cardiac output synfrome
Serious: yes
Organ System: Cardiac disorders
Notes: Low cardiac output synfrome when cardiac index \<2.2
Frequency: 15 affected / 175 at risk

Adverse event: Low cardiac output synfrome
Serious: yes
Organ System: Cardiac disorders
Notes: Low cardiac output synfrome when cardiac index \<2.2
Frequency: 1 affected / 27 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 27 at risk
Study: NCT03050554

Adverse event: Cholecystitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Cholecystitis
Frequency: 1 affected / 2 at risk

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

Adverse event: Left Rib Pain with Deep Inspiration
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Left Rib Pain with Deep Inspiration
Frequency: 1 affected / 2 at risk

Adverse event: Infusion related reaction
Serious: no
Organ System: General disorders
Notes: Infusion reaction
Frequency: 1 affected / 2 at risk

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

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

Adverse event: Right Eye Pain and Redness
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Notes: Right eye
Frequency: 1 affected / 2 at risk

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

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 2 at risk

Adverse event: Black Skin Tags
Serious: no
Organ System: Skin and subcutaneous tissue 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: Hypocalcaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 2 at risk
Study: NCT03050697

Adverse event: Astigmatism
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Macular oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 17 at risk

Adverse event: Procedural complication
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Recorded as ciliary zonular dehiscence in Outcome Measure 13
Frequency: 1 affected / 17 at risk

Adverse event: Intra-ocular injection
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 17 at risk

Adverse event: Vitrectomy
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 17 at risk
Study: NCT03050775

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 35 at risk

Adverse event: Blood clot
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 35 at risk

Adverse event: Infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 34 at risk
Study: NCT03050801

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 21 at risk

Adverse event: Intolerance to stimulation
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 4 at risk
Study: NCT03051620

Adverse event: Neoplasm malignant
Serious: yes
Organ System: Investigations
Frequency: 7 affected / 142 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 142 at risk

Adverse event: Arrhythmia, acute myocardial infarction, hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 10 affected / 142 at risk

Adverse event: Cataract, glaucoma
Serious: no
Organ System: Eye disorders
Frequency: 9 affected / 142 at risk

Adverse event: Lower urinary symptoms, infection and kidney stones
Serious: no
Organ System: Renal and urinary disorders
Frequency: 9 affected / 142 at risk

Adverse event: Arthralgia, osteoarthritis, back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 142 at risk

Adverse event: Upper and lower respiratory tract infection, pneumonia, bronchitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 142 at risk
Study: NCT03052049

Adverse event: Renal and Urinary Adverse Events
Serious: no
Organ System: Renal and urinary disorders
Notes: Events associated with urinary tract or genital region, damage to bladder floor, trigone, sphincters, rectum, incontinence, infections, secondary surgical interventions, transient post procedure events, deaths
Frequency: 10 affected / 26 at risk
Study: NCT03052257

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 3 affected / 100 at risk

Adverse event: Hospitalisation
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 100 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 100 at risk
Study: NCT03052400

Adverse event: Worsening of heart failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

Adverse event: Work-related injury
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 3 at risk

Adverse event: Myalgias
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Prolonged QT Interval
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 3 at risk

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

Adverse event: Work-related injury
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 3 at risk
Study: NCT03052530

Adverse event: Myocardial infarction
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 61 at risk
Study: NCT03052725

Adverse event: Abdominal distension
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Dysphagia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 390 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 390 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Peritonsillar abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 390 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 390 at risk

Adverse event: Post procedural haematoma
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 390 at risk

Adverse event: Neck pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 390 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 390 at risk

Adverse event: Synovial cyst
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 390 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 390 at risk

Adverse event: Abortion spontaneous
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 390 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 390 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 390 at risk

Adverse event: Hypertensive crisis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 390 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 390 at risk

Adverse event: Viral upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 49 affected / 390 at risk
Study: NCT03052764

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 78 at risk

Adverse event: Acute coronary syndrome
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 78 at risk

Adverse event: Haematochezia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Post procedural cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Urosepsis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 78 at risk

Adverse event: Breast cancer recurrent
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 78 at risk

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

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 78 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 78 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 28 affected / 78 at risk

Adverse event: Cellulitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 39 at risk

Adverse event: Urinary bladder haemorrhage
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 39 at risk

Adverse event: Productive cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 39 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 39 at risk

Adverse event: Arteriosclerosis coronary artery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 58 at risk

Adverse event: Chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 58 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 58 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 58 at risk

Adverse event: Troponin increased
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 33 at risk

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

Adverse event: Dysuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 33 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 33 at risk
Study: NCT03052920

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: at surgical site
Frequency: 1 affected / 40 at risk

Adverse event: Coronary angioplasty and stint
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 40 at risk

Adverse event: Gall bladder removal
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 40 at risk

Adverse event: Nausea
Serious: yes
Organ System: General disorders
Notes: Result of anesthesia
Frequency: 1 affected / 40 at risk

Adverse event: Kidney stone removal
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 40 at risk

Adverse event: Tear of medial meniscus
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 40 at risk

Adverse event: Heart bypass surgery
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 40 at risk

Adverse event: Dizziness
Serious: no
Organ System: Ear and labyrinth disorders
Notes: onset or worsening
Frequency: 7 affected / 40 at risk

Adverse event: Tinnitus
Serious: no
Organ System: Ear and labyrinth disorders
Notes: onset or worsening
Frequency: 2 affected / 40 at risk

Adverse event: Swelling
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Swelling over the cochlear implant receiver/stimulator
Frequency: 2 affected / 40 at risk
Study: NCT03052972

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 18 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk
Study: NCT03053180

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 60 at risk

Adverse event: Ascariasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 60 at risk
Study: NCT03053271

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

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

Adverse event: Ear discomfort
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 4 at risk

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

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

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

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

Adverse event: Skin laceration
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 4 at risk

Adverse event: Hepatic enzyme increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 4 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 4 at risk
Study: NCT03053362

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Variable degree and duration of nausea experienced by participants with major depression taking vortioxetine. This was an expected side effect of the medication.
Frequency: 42 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 100 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 15 affected / 100 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 100 at risk

Adverse event: Dizziness/Lightheadedness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 100 at risk

Adverse event: Itchiness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 5 affected / 100 at risk
Study: NCT03053427

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 186 at risk

Adverse event: Somnolence neonatal
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 186 at risk

Adverse event: Colitis ischaemic
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 189 at risk

Adverse event: Anaphylactic reaction
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 189 at risk

Adverse event: Femur fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 189 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 24 affected / 189 at risk

Adverse event: Somnolence neonatal
Serious: no
Organ System: Nervous system disorders
Frequency: 25 affected / 189 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 20 affected / 189 at risk