TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT04074343

Adverse event: Febrile neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 14 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 20 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 20 at risk

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

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Frequency: 6 affected / 20 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Alopecia
Serious: no
Organ System: Immune system disorders
Frequency: 4 affected / 20 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 20 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 3 affected / 20 at risk

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

Adverse event: Hypotention
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 20 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 20 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk

Adverse event: White blood cell count decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 20 at risk
Study: NCT04074590

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 16 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 16 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 16 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 16 at risk

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 7 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: Drug-induced liver injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 7 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 7 at risk

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

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

Adverse event: Atrioventricular block first degree
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 23 at risk

Adverse event: Colitis ulcerative
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 23 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 23 at risk

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

Adverse event: Drug-induced liver injury
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 23 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 23 at risk

Adverse event: Faecal calprotectin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

Adverse event: Urine protein/creatinine ratio increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 23 at risk

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 23 at risk
Study: NCT04074616

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 25 at risk

Adverse event: Decubitus ulcer
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 25 at risk

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

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 25 at risk

Adverse event: COVID
Serious: no
Organ System: General disorders
Frequency: 1 affected / 25 at risk
Study: NCT04074941

Adverse event: High blood glucose in participants with baseline diabetes
Serious: no
Organ System: Endocrine disorders
Notes: Self-reported
Frequency: 2 affected / 9 at risk
Study: NCT04075513

Adverse event: Hypoglycaemic seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 172 at risk

Adverse event: Hypoglycaemic unconsciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 4 affected / 172 at risk

Adverse event: Orthostatic intolerance
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 172 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 171 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 4 affected / 171 at risk

Adverse event: Hypoglycaemic unconsciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 171 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 171 at risk

Adverse event: Accidental overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 171 at risk
Study: NCT04075682

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: One participant in the inserts only condition was found to have been hospitalized after experiencing a heart attack when the study team followed up with him to determine why he had stopped logging cigarettes and surveys.
Frequency: 1 affected / 94 at risk

Adverse event: Mini stroke
Serious: yes
Organ System: Vascular disorders
Notes: One participant in the pictorial warning only group was found to have experienced what he termed a "mini stroke" when the study team followed up with him to determine why he had stopped logging cigarettes and surveys.
Frequency: 1 affected / 94 at risk
Study: NCT04075812

Adverse event: Device-related SAE (anticipated)
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin irritation/burns
Frequency: 1 affected / 2 at risk

Adverse event: Non-device related AE associated with spinal cord injury (anticipated)
Serious: no
Organ System: Renal and urinary disorders
Notes: Urinary tract infections and/or stones associated with neurogenic bladder
Frequency: 2 affected / 2 at risk

Adverse event: Non-device related AE associated with spinal cord injury (anticipated)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Deep tissue injury complications
Frequency: 1 affected / 2 at risk
Study: NCT04076293

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 6 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 6 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 3 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Injection site bruising
Serious: no
Organ System: General disorders
Frequency: 2 affected / 10 at risk

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

Adverse event: Neutrophil count decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 10 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk
Study: NCT04076540

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infrequent bowel movements
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Medical device site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 12 at risk

Adverse event: Orthostatic hypotension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 12 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Ventricular tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk

Adverse event: Medical device site dermatitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk
Study: NCT04076917

Adverse event: Postoperative wound infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk

Adverse event: Cellulitis at implant site
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 84 at risk
Study: NCT04078126

Adverse event: Angina pectoris
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 33 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 35 at risk
Study: NCT04078178

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 22 at risk

Adverse event: Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 22 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 20 at risk

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

Adverse event: Fall
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 20 at risk

Adverse event: Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 3 affected / 20 at risk

Adverse event: Dizziness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 18 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 18 at risk

Adverse event: Cramping
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 18 at risk
Study: NCT04079114

Adverse event: Femoral Implant Fracture
Serious: yes
Organ System: Surgical and medical procedures
Notes: Treated by change of the Stem
Frequency: 1 affected / 166 at risk

Adverse event: Death (Stroke)
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 166 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Treated by lavage and antibiotic.
Frequency: 1 affected / 166 at risk

Adverse event: Deep Infection <6 Weeks
Serious: yes
Organ System: Infections and infestations
Notes: Treated by lavage and antibiotic.
Frequency: 1 affected / 166 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Notes: Treated by 2 Red cell transfusion
Frequency: 1 affected / 166 at risk

Adverse event: Deep Infection <6 Weeks
Serious: no
Organ System: Infections and infestations
Notes: Treated by lavage and antibiotic
Frequency: 1 affected / 166 at risk

Adverse event: Cerebrovascular accident
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 166 at risk

Adverse event: Peroperative fracture of the femur
Serious: no
Organ System: Surgical and medical procedures
Notes: Treated by peroperative cerclage of the femur.
Frequency: 1 affected / 166 at risk

Adverse event: Vascular injury
Serious: no
Organ System: Vascular disorders
Notes: Treated by suture and vascular surgical exploration
Frequency: 1 affected / 166 at risk

Adverse event: Femur fracture
Serious: no
Organ System: Surgical and medical procedures
Notes: Treated by plate osteosynthesis.
Frequency: 1 affected / 166 at risk

Adverse event: Pseudoarthrosis
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Treated by implantation of a nail.
Frequency: 1 affected / 166 at risk

Adverse event: Suspicion infection
Serious: no
Organ System: Infections and infestations
Notes: Hospitalization
Frequency: 1 affected / 166 at risk

Adverse event: Axonal mononeuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Treated by move of the knee.
Frequency: 1 affected / 166 at risk

Adverse event: Total Knee Arthroplasty Left
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 166 at risk

Adverse event: Fall
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 166 at risk

Adverse event: Fracture of Trochanter
Serious: no
Organ System: Surgical and medical procedures
Notes: Treated by Cerclage
Frequency: 1 affected / 166 at risk

Adverse event: Haematoma
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Treated by Lavage and antibiotic
Frequency: 1 affected / 166 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Notes: Treated by change of the heart treatment.
Frequency: 1 affected / 166 at risk

Adverse event: Transfusion reaction
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 166 at risk
Study: NCT04079452

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 15 at risk
Study: NCT04079803

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

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 22 at risk

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

Adverse event: Any adverse event
Serious: no
Organ System: General disorders
Frequency: 12 affected / 22 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 21 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 21 at risk

Adverse event: Any adverse event
Serious: no
Organ System: General disorders
Frequency: 9 affected / 21 at risk

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

Adverse event: Fatigue
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 21 at risk

Adverse event: Any adverse event
Serious: no
Organ System: General disorders
Frequency: 4 affected / 21 at risk
Study: NCT04080297

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 10 at risk

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

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

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

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Hypertriglyceridaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 10 at risk

Adverse event: Haematuria
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 10 at risk

Adverse event: Vulvovaginal burning sensation
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 10 at risk

Adverse event: Breast pain
Serious: yes
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Blood thyroid stimulating hormone increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Blood triglycerides increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Blood uric acid increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Weight increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 11 at risk

Adverse event: Coordination abnormal
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 11 at risk

Adverse event: Insomnia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Oral herpes
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Euphoric mood
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 11 at risk

Adverse event: Flank pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 11 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: Breast pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk

Adverse event: Breast mass
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk
Study: NCT04080544

Adverse event: Elevated blood pressure
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: AE resolved by 48-72 hour follow-up call.
Frequency: 9 affected / 125 at risk

Adverse event: Black dot in visual field
Serious: no
Organ System: Eye disorders
Notes: AE resolved by 48-72 hour follow-up call.
Frequency: 1 affected / 125 at risk

Adverse event: Muscle soreness in injection arm
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: AE resolved by 48-72 hour follow-up call.
Frequency: 1 affected / 125 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: AE resolved by 48-72 hour follow-up call.
Frequency: 1 affected / 125 at risk

Adverse event: Diarrhea, drowsiness, nausea
Serious: no
Organ System: General disorders
Notes: AE resolved by 48-72 hour follow-up call.
Frequency: 1 affected / 125 at risk
Study: NCT04080752

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 112 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 112 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 112 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 110 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 110 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 3 affected / 110 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 110 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 110 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 110 at risk