TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02336607

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 85 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 7 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 85 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 85 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 92 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 5 affected / 92 at risk

Adverse event: Gastrointestinal system damage
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Not considered drug related according to the investigator.
Frequency: 1 affected / 260 at risk

Adverse event: Nervous system damage
Serious: yes
Organ System: Nervous system disorders
Notes: Not considered drug related according to the investigator.
Frequency: 1 affected / 260 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 33 affected / 260 at risk

Adverse event: Flushing
Serious: no
Organ System: Vascular disorders
Frequency: 13 affected / 260 at risk
Study: NCT02336737

Adverse event: Breast discolouration/hyperpigmentation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 23 affected / 147 at risk
Study: NCT02336958

Adverse event: definitive stroke
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: temporarily hoarseness
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 20 at risk

Adverse event: temporarily dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 20 at risk

Adverse event: Horner syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 20 at risk

Adverse event: temporarily paresis of the hypoglossal nerve
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 20 at risk

Adverse event: temporarily hoarseness
Serious: no
Organ System: Nervous system disorders
Frequency: 11 affected / 20 at risk

Adverse event: temporarily dysphagia
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 20 at risk

Adverse event: Cough
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Horner syndrome
Serious: no
Organ System: Nervous system disorders
Frequency: 4 affected / 20 at risk

Adverse event: temporarily paresis of the hypoglossal nerve
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 20 at risk
Study: NCT02337634

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 26 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 26 at risk

Adverse event: Increased appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 26 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 17 at risk

Adverse event: Reduced appetite
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 17 at risk
Study: NCT02337725

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 126 at risk

Adverse event: Gastric ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 126 at risk

Adverse event: Herpes zoster
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 126 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 126 at risk

Adverse event: Cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Cubital tunnel syndrome
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Thrombotic cerebral infarction
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 126 at risk

Adverse event: Completed suicide
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 126 at risk

Adverse event: Aortic dissection
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 126 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 19 affected / 126 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 7 affected / 126 at risk

Adverse event: Leukoplakia oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 18 affected / 117 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 117 at risk
Study: NCT02337751

Adverse event: Mechanical ileus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 95 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 95 at risk

Adverse event: Prostate cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 95 at risk

Adverse event: Microscopic polyangiitis
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 95 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 17 affected / 95 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 6 affected / 95 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 95 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 95 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 95 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Leukoplakia oral
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 117 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 117 at risk

Adverse event: Femoral neck fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Compression fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 117 at risk

Adverse event: Intracranial aneurysm
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 117 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 117 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 11 affected / 117 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 5 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 117 at risk

Adverse event: Eczema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 117 at risk
Study: NCT02337933

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 12 at risk

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

Adverse event: Abdominal distention
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 12 at risk
Study: NCT02338193

Adverse event: Fungal infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 20 at risk

Adverse event: Nausea/diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 20 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 6 affected / 21 at risk

Adverse event: Nausea/diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 25 at risk
Study: NCT02338336

Adverse event: Burning/stinging
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 9 affected / 26 at risk

Adverse event: Dryness
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 26 at risk

Adverse event: Oedema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 26 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain on treated area
Frequency: 2 affected / 26 at risk

Adverse event: Pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Pain on treated area
Frequency: 1 affected / 28 at risk
Study: NCT02338362

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

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

Adverse event: Oropharyngeal pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk

Adverse event: Insomnia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 10 at risk
Study: NCT02338713

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 27 at risk
Study: NCT02338973

Adverse event: Visual acuity reduced
Serious: yes
Organ System: Eye disorders
Notes: Decreased vision in OS
Frequency: 1 affected / 4 at risk

Adverse event: Ocular hyperaemia
Serious: no
Organ System: Eye disorders
Notes: Mild Redness.
Frequency: 1 affected / 4 at risk

Adverse event: Lacrimation increased
Serious: no
Organ System: Eye disorders
Notes: Tearing
Frequency: 1 affected / 4 at risk

Adverse event: Eye pruritus
Serious: no
Organ System: Eye disorders
Notes: Itching
Frequency: 1 affected / 4 at risk

Adverse event: Cystoid macular oedema
Serious: no
Organ System: Eye disorders
Notes: Mild Blurring of Vision Due to Worse CME OD
Frequency: 1 affected / 4 at risk

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

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Back Pain
Frequency: 1 affected / 4 at risk

Adverse event: Retinal telangiectasia
Serious: no
Organ System: Eye disorders
Notes: Idiopathic Juxtafoveal heme
Frequency: 1 affected / 4 at risk

Adverse event: Diabetic retinopathy
Serious: no
Organ System: Eye disorders
Notes: Dot and Blot Heme OS
Frequency: 1 affected / 4 at risk
Study: NCT02339038

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 45 affected / 600 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 40 affected / 600 at risk
Study: NCT02339233

Adverse event: Device malfunction
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 8 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk

Adverse event: Flipped Stimulator
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 8 at risk

Adverse event: Electrode Malfunction
Serious: no
Organ System: Surgical and medical procedures
Frequency: 1 affected / 8 at risk

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

Adverse event: Right Ankle Edema
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 8 at risk
Study: NCT02339246

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 2 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 31 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Frequency: 3 affected / 31 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 31 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 31 at risk
Study: NCT02339506

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: Subject vomited during study, likely due to GI illness.
Frequency: 1 affected / 22 at risk

Adverse event: Subject had less blood drawn
Serious: no
Organ System: General disorders
Notes: Subject with normal Hct at screen (37.8), had low Hct on admission (30.8 and 31.9). Due to general wellness the study proceeded; blood draws were reduced to primary endpoints/safety and only about 40cc of blood were drawn (reduced from about 165 cc).
Frequency: 1 affected / 22 at risk
Study: NCT02339584

Adverse event: Deafness neurosensory
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 1 affected / 188 at risk

Adverse event: Pancreatitis acute
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 188 at risk

Adverse event: Ligament injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 188 at risk

Adverse event: Renal colic
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 188 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 12 affected / 188 at risk

Adverse event: Gastritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 191 at risk

Adverse event: Diabetic neuropathy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 191 at risk

Adverse event: Vocal cord leukoplakia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 191 at risk

Adverse event: Conjunctival hyperaemia
Serious: no
Organ System: Eye disorders
Frequency: 13 affected / 191 at risk
Study: NCT02339909

Adverse event: Patient invited and not suitable for screening
Serious: no
Organ System: Investigations
Notes: Patients invited and attending, who are not suitable for screening are considered an adverse event in this trial
Frequency: 1 affected / 312 at risk
Study: NCT02340000

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: vaginal itching or discharge at day 3
Frequency: 3 affected / 87 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea at day 3
Frequency: 30 affected / 87 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: vaginal itching or discharge at day 3
Frequency: 11 affected / 80 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea at day 3
Frequency: 37 affected / 80 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: vaginal itching or discharge at day 3
Frequency: 4 affected / 62 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea at day 3
Frequency: 19 affected / 62 at risk

Adverse event: Vaginal infection
Serious: no
Organ System: Infections and infestations
Notes: vaginal itching or discharge at day 3
Frequency: 7 affected / 57 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: diarrhea at day 3
Frequency: 27 affected / 57 at risk
Study: NCT02340026

Adverse event: Fall in a toddler
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Developmentally-appropriate falls in our toddler age cohorts. The child needed a 1-5 minute break after the fall, then resumed study procedures as planned. Three falls occurred during a treatment session, one occurred during an assessment session.
Frequency: 3 affected / 21 at risk

Adverse event: Fall in a toddler
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Developmentally-appropriate falls in our toddler age cohorts. The child needed a 1-5 minute break after the fall, then resumed study procedures as planned. Three falls occurred during a treatment session, one occurred during an assessment session.
Frequency: 1 affected / 20 at risk
Study: NCT02340078

Adverse event: Administration Site Conditions
Serious: no
Organ System: General disorders
Notes: In detail, 'Injection Site Discomfort' were 3 cases, showing the highest incidence.
Frequency: 3 affected / 62 at risk
Study: NCT02340091

Adverse event: Nasopharyngitis
Serious: yes
Organ System: Infections and infestations
Notes: 'continuous' occurrence, the severity was 'Moderate', the relationship was 'Not related', and the outcome was 'Recovered'.
Frequency: 1 affected / 62 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 62 at risk
Study: NCT02340104

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

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

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 8 at risk
Study: NCT02340156

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

Adverse event: Electrocardiogram QT prolonged
Serious: no
Organ System: Investigations
Frequency: 1 affected / 1 at risk

Adverse event: Skin ulcer
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1 at risk
Study: NCT02340299

Adverse event: Highly viscous secretions
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 4 at risk
Study: NCT02340338

Adverse event: Mild to moderate reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Mild to moderate reactions
Serious: no
Organ System: General disorders
Frequency: 1 affected / 2 at risk

Adverse event: Mild to moderate reactions
Serious: no
Organ System: General disorders
Frequency: 2 affected / 3 at risk

Adverse event: Mild to moderate reactions
Serious: no
Organ System: General disorders
Frequency: 7 affected / 9 at risk

Adverse event: Mild to moderate reactions
Serious: no
Organ System: General disorders
Frequency: 8 affected / 9 at risk

Adverse event: Mild to moderate reactions
Serious: no
Organ System: General disorders
Frequency: 7 affected / 9 at risk

Adverse event: Mild to moderate reactions
Serious: no
Organ System: General disorders
Frequency: 9 affected / 12 at risk
Study: NCT02340663

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Tape sensitivity
Frequency: 1 affected / 32 at risk

Adverse event: Mucosal Bleeding Spot
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Scrape by subject during splint insertion
Frequency: 1 affected / 32 at risk

Adverse event: Tooth Chipped
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk
Study: NCT02340676

Adverse event: Bronchiolitis obliterans syndrome
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 Participant passed away to Grad5 Bronchiolitis Obliterans Syndrome. Expected and unrelated to study treatment.
Frequency: 1 affected / 25 at risk

Adverse event: Parainfluenza Type 3
Serious: yes
Organ System: Infections and infestations
Notes: 1 Participant passed away due to Grade 5 Parainfluenza Type 3. Expected and unrelated to study treatment.
Frequency: 1 affected / 25 at risk

Adverse event: Cardiac arrest
Serious: yes
Organ System: Cardiac disorders
Notes: 1 Participant passed away to Grade 5 Cardiac Arrest. Unexpected and unrelated to study treatment.
Frequency: 1 affected / 25 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: 1 Participant experienced Grade 2 Cough. Unexpected and possible to study treatment.
Frequency: 1 affected / 25 at risk

Adverse event: Acute Limb Schemia
Serious: no
Organ System: Vascular disorders
Notes: 1 Participant experienced Grade 3 Acute Limb Ischemia. Unexpected and possible to study treatment.
Frequency: 1 affected / 25 at risk
Study: NCT02341235

Adverse event: Hospitalisation
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Breast reconstruction surgery
Frequency: 1 affected / 45 at risk

Adverse event: Broken toe
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Herpes zoster
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 45 at risk

Adverse event: Achilles tendon tear
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

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

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Chest pain
Frequency: 1 affected / 45 at risk

Adverse event: Back pain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 45 at risk