TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT02878213

Adverse event: Transient ischaemic attack
Serious: yes
Organ System: Nervous system disorders
Notes: The patient has developed signs of stroke following transseptal before cardiac mapping of the left atrium was initiated. The procedure was immediately aborted. All neurological deficits have resolved within a few days while in hospitalization.
Frequency: 1 affected / 39 at risk
Study: NCT02878343

Adverse event: Aortic valve replacement
Serious: yes
Organ System: Cardiac disorders
Notes: Diagnostic tests showed enlarged heart, leakage from aortic valve, and a hole in his heart. Aortic valve replacement/repair of hole in heart on 10/1/15. Good reports on 2 post-op checkups. Prescribed 2-3 months of cardiac rehab.
Frequency: 1 affected / 86 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Involved in a vehicular accident, fractured C 3,4,5 vertebrae; surgery on 8/10/15 w/placement of titanium plates and a soft cast. Two post-op appointments; cleared and no recommended rehab.
Frequency: 1 affected / 86 at risk

Adverse event: Headaches and dizziness
Serious: yes
Organ System: General disorders
Notes: Subject had recurring headaches with some episodes of dizziness upon standing. MRI revealed white lesions on brain, caused by HBP. Originally diagnosed with HBP in 7/2015 \& on Clonidine. BP was normal range at last 2 visits to PCP.
Frequency: 1 affected / 86 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Heart attack, admitted on 8/15, discharged on 8/20; cardiac therapy protocol at Penn Presby., returned to work 10/15
Frequency: 1 affected / 86 at risk

Adverse event: Brain hemorrhage
Serious: yes
Organ System: Vascular disorders
Notes: Admitted to ER, tests reveal brain hemorrhage; cause unknown. Had 2 seizures while in transport to ER. Emergency surgery to release pressure on the brain, w/successful outcome. Prescribed 2yr. regimen of Keppra.
Frequency: 1 affected / 86 at risk
Study: NCT02878382

Adverse event: local skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: erythema, edema, crusts and pustules.
Frequency: 15 affected / 20 at risk

Adverse event: local skin reactions
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: erythema, edema, crusts and pustules.
Frequency: 12 affected / 20 at risk
Study: NCT02878486

Adverse event: IV site irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: skin irritation at the site of IV used for blood collection
Frequency: 1 affected / 2 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash at the site of adhesive used to attach monitoring device
Frequency: 1 affected / 3 at risk
Study: NCT02878590

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Subject reported they were not feeling well earlier in the day and had chest discomfort, but was now feeling better and came in at night for the PSG with the device.
Frequency: 1 affected / 23 at risk

Adverse event: Nasal abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Subject reported that they had a nasal abrasion so they opted to not wear the device one of the days at home. Subject wore the device on subsequent days, including at the PSG with the device with no further reported events.
Frequency: 1 affected / 23 at risk
Study: NCT02878785

Adverse event: Respiratory
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 8 affected / 25 at risk

Adverse event: Infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Infection, lung
Frequency: 15 affected / 25 at risk

Adverse event: Sepsis/bacteremia
Serious: yes
Organ System: Infections and infestations
Frequency: 12 affected / 25 at risk

Adverse event: Fungal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 25 at risk

Adverse event: Other infections
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 25 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: Infections and infestations
Frequency: 19 affected / 25 at risk

Adverse event: Intracranial bleed
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 25 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 25 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 25 at risk

Adverse event: Vomiting
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 25 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 25 at risk

Adverse event: Hypertransaminasaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 4 affected / 25 at risk

Adverse event: Elevated creatinine
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 25 at risk

Adverse event: Respiratory
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 25 at risk

Adverse event: Other infections
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 25 at risk

Adverse event: Other infections
Serious: no
Organ System: Infections and infestations
Frequency: 5 affected / 25 at risk

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

Adverse event: Atrial fibrillation
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 25 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 25 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 25 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 13 affected / 25 at risk

Adverse event: Hypertransaminasaemia
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 3 affected / 25 at risk

Adverse event: Elevated creatinine
Serious: no
Organ System: Renal and urinary disorders
Frequency: 2 affected / 25 at risk
Study: NCT02879747

Adverse event: Otitis media
Serious: yes
Organ System: Ear and labyrinth disorders
Notes: Otitis media with perforation needed hospitalization
Frequency: 1 affected / 27 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization for risk of appendicitis
Frequency: 1 affected / 27 at risk

Adverse event: facial nerve palsy due to tick disease
Serious: yes
Organ System: Infections and infestations
Notes: Hospitalization due to need for intravenous antibiotic treatment
Frequency: 1 affected / 27 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Common adverse event was virosis winter-time
Frequency: 20 affected / 27 at risk

Adverse event: Abdominal pain
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Hospitalization for risk of appendicitis
Frequency: 1 affected / 38 at risk

Adverse event: Accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Hospitalization due to car accident
Frequency: 1 affected / 38 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fracture after falling from a tree
Frequency: 2 affected / 38 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Common adverse event was virosis winter-time
Frequency: 25 affected / 38 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Fracture after falling from a tree
Frequency: 1 affected / 33 at risk

Adverse event: Urinary tract infection (upper)
Serious: yes
Organ System: Infections and infestations
Notes: Urinary tract infection with hospitalization
Frequency: 2 affected / 33 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Notes: Common adverse event was virosis winter-time
Frequency: 24 affected / 33 at risk
Study: NCT02879994

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Pneumonitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypotension
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 11 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

Adverse event: Elevated alanine aminotransferase
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 11 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 11 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 11 at risk

Adverse event: Adrenal insufficiency
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 11 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 11 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 2 affected / 11 at risk

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

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 11 at risk

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

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

Adverse event: Alanine aminotransferase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Aspartate aminotransferase increased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Thyroid-stimulating hormone decreased
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 11 at risk
Study: NCT02880189

Adverse event: Abdominal pain upper
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 21 at risk

Adverse event: Laryngospasm
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 21 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 21 at risk

Adverse event: Non-ST-elevation myocardial infarction (NSTEMI)
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 21 at risk
Study: NCT02880241

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 8 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Oral discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 8 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 8 at risk

Adverse event: Ascariasis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Carbuncle
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Hookworm infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: P.falciparum infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 8 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 8 at risk

Adverse event: Neutropenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 8 at risk

Adverse event: Sinus tachycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 8 at risk

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

Adverse event: Haemoglobin decreased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 8 at risk

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

Adverse event: Urinary tract discomfort
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 8 at risk
Study: NCT02880319

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Notes: Patient presented with new onset atrial fibrillation with a rapid ventricular response after receiving his chemotherapy regimen. He was treated with an IV of diltiazem, and prescribed heparin and coumadin after consult.
Frequency: 1 affected / 98 at risk

Adverse event: Prolonged hospitalization/Severe esophagitis
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient developed severe esophagitis requiring hospitalization and IV fluids over several days (grade 3). His symptoms improved with opioid medication optimization and he was discharged several days later.
Frequency: 1 affected / 98 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 10 affected / 98 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 15 affected / 98 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 98 at risk

Adverse event: Hospitalization due to pain at an unrelated metastatic site
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Patient returned for protocol treatment and reported having increasing groin pain for 4 weeks. CT scan showed an increased left illiac bone lesion causing cortical destruction.
Frequency: 1 affected / 44 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 24 affected / 44 at risk

Adverse event: Gastrointestinal
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 44 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 28 affected / 44 at risk
Study: NCT02880514

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

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 50 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk
Study: NCT02880761

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Newly happened acute myocardial infarction.
Frequency: 2 affected / 103 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 103 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 103 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Notes: Newly happened acute myocardial infarction.
Frequency: 5 affected / 106 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 3 affected / 106 at risk

Adverse event: Fracture
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 106 at risk
Study: NCT02880852

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

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 20 at risk

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

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

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 20 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 20 at risk

Adverse event: Hypokalaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 20 at risk

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

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

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

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

Adverse event: Balanoposthitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 20 at risk
Study: NCT02881047

Adverse event: Left Brachial artery clot
Serious: yes
Organ System: Cardiac disorders
Notes: Pt complained of L arm cramping beginning 1/21 was diagnosed with brachial artery clot on 1/26. Went to OR for thrombectomy. Now doing fine, anticoagulated. Please note laser treatment #1 for this study took place on 1/22 on contralateral wrist.
Frequency: 1 affected / 8 at risk

Adverse event: Biopsy site infection
Serious: yes
Organ System: Infections and infestations
Notes: Pt experienced pain at the right forearm skin biopsy site the same day of the biopsy. Later developed scant fibrinous exudate vs minimal purulent drainage, possibly representing superficial skin infection.
Frequency: 1 affected / 8 at risk

Adverse event: Pain at Treatment site (right foot)
Serious: no
Organ System: Nervous system disorders
Notes: Pt ( has existing lower extremity neuropathy) developed pain at laser treatment site within \~1 hour of treatment. Pain was moderate to severe but transient resolved with conservative measures Treatment discontinuation for this patient due to pain.
Frequency: 1 affected / 8 at risk
Study: NCT02881151

Adverse event: Infection of DBS device
Serious: yes
Organ System: Infections and infestations
Notes: Infection of deep brain stimulator system, requiring removal
Frequency: 1 affected / 6 at risk

Adverse event: Syncope
Serious: yes
Organ System: Nervous system disorders
Notes: Syncope when standing to urinate
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Wound site bleeding
Serious: no
Organ System: Surgical and medical procedures
Notes: Scabbing at surgical site with small amount of bleeding
Frequency: 1 affected / 6 at risk

Adverse event: Unintended stimulator deactivation
Serious: no
Organ System: Product Issues
Notes: Stimulator de-activated unintentionally (felt to be due to theft detector in store)
Frequency: 1 affected / 6 at risk

Adverse event: Gait disturbance
Serious: no
Organ System: Nervous system disorders
Notes: Gait unsteadiness (self limited)
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: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 6 at risk

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

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

Adverse event: Cognitive difficulty
Serious: no
Organ System: Nervous system disorders
Notes: Difficulty with planning, organization and word recall
Frequency: 1 affected / 6 at risk

Adverse event: COVID-19
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 6 at risk
Study: NCT02881567

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 41 at risk

Adverse event: Gastrointestinal ulcer
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 41 at risk

Adverse event: Cholelithiasis
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 41 at risk

Adverse event: Encephalitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Influenza
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Oesophageal candidiasis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Subcutaneous abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 41 at risk

Adverse event: Rhabdomyolysis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Multiple sclerosis relapse
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 41 at risk

Adverse event: Drug reaction with eosinophilia and systemic symptoms
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 41 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 41 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 41 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 7 affected / 41 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 41 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 4 affected / 41 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 41 at risk

Adverse event: Multiple sclerosis relapse
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 41 at risk

Adverse event: Depression
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 41 at risk