TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT00978042

Adverse event: Inflammation
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Injection site mass
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 270 at risk

Adverse event: Basal cell carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 270 at risk

Adverse event: Carcinoid tumour pulmonary
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 270 at risk

Adverse event: Squamous cell carcinoma of skin
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 270 at risk

Adverse event: Thyroid cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 270 at risk

Adverse event: Optic ischaemic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 270 at risk

Adverse event: Optic neuropathy
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 270 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 270 at risk

Adverse event: Humerus fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 270 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 270 at risk

Adverse event: Skin mass
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 270 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Notes: Administration site condition
Frequency: 54 affected / 270 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Administration site condition
Frequency: 39 affected / 270 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Administration site condition
Frequency: 21 affected / 270 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Administration site condition
Frequency: 17 affected / 270 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 167 at risk

Adverse event: Hip fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 167 at risk

Adverse event: Injection site mass
Serious: no
Organ System: General disorders
Notes: Administration site condition
Frequency: 8 affected / 167 at risk

Adverse event: Injection site induration
Serious: no
Organ System: General disorders
Notes: Administration site condition
Frequency: 7 affected / 167 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Notes: Administration site condition
Frequency: 1 affected / 167 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Notes: Administration site condition
Frequency: 1 affected / 167 at risk
Study: NCT00978562

Adverse event: Shunt malfunction and revision
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 14 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 14 at risk

Adverse event: Diplopia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nystagmus
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Seizure
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Dry skin
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: teleangiectasia
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Body aches
Serious: no
Organ System: General disorders
Frequency: 1 affected / 14 at risk

Adverse event: Shunt infection
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk
Study: NCT00979199

Adverse event: Severe chest pain
Serious: no
Organ System: Cardiac disorders
Frequency: 5 affected / 475 at risk
Study: NCT00979303

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Groin hematoma
Frequency: 5 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 37 at risk

Adverse event: Groin pain
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Groin pain 1 week after discharge
Frequency: 1 affected / 37 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Skin abrasion
Frequency: 1 affected / 37 at risk

Adverse event: Haematoma
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Groin hematoma
Frequency: 3 affected / 37 at risk

Adverse event: Bronchospasm
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Brochospasm after adenosine
Frequency: 1 affected / 37 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Headache
Frequency: 1 affected / 37 at risk

Adverse event: Vasovagal syncope
Serious: no
Organ System: Nervous system disorders
Notes: Vasovagal syncope
Frequency: 1 affected / 37 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Notes: Neuropathy
Frequency: 1 affected / 37 at risk

Adverse event: Mechanical trauma to pathway
Serious: no
Organ System: Cardiac disorders
Notes: Trauma to pathway
Frequency: 1 affected / 37 at risk
Study: NCT00979459

Adverse event: Vessel puncture site haematoma
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

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

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 12 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

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

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

Adverse event: Chest pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infusion site haematoma
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infusion site inflammation
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 12 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 12 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk
Study: NCT00979615

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 63 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 63 at risk

Adverse event: Taste disorder
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 66 at risk

Adverse event: Epistaxis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 66 at risk
Study: NCT00979628

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: blood glucose \< 40 mg/dl
Frequency: 1 affected / 133 at risk

Adverse event: wound infections
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 133 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 133 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 8 affected / 133 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 133 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: blood glucose \< 70 mg/dl
Frequency: 16 affected / 133 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Notes: blood glucose \< 40 mg/dl
Frequency: 1 affected / 144 at risk

Adverse event: wound infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 144 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 144 at risk

Adverse event: Acute respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 144 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 9 affected / 144 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 7 affected / 144 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: blood glucose \< 70 mg/dl
Frequency: 13 affected / 144 at risk

Adverse event: wound infections
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Acute kidney injury
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 3 affected / 74 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 74 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: blood glucose \< 70 mg/dl
Frequency: 3 affected / 74 at risk
Study: NCT00979745

Adverse event: Implant site discolouration
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 38 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 38 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 38 at risk

Adverse event: Dizziness
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 38 at risk

Adverse event: Pigmentation disorder
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 38 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Investigations
Frequency: 2 affected / 36 at risk

Adverse event: Gamma-glutamyltransferase increased
Serious: no
Organ System: Investigations
Frequency: 3 affected / 36 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 36 at risk
Study: NCT00979875

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Notes: The Organ System includes "administration site conditions."
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infusion site abscess
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 14 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infusion site anaesthesia
Serious: no
Organ System: General disorders
Notes: The Organ System includes "administration site conditions."
Frequency: 1 affected / 14 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 14 at risk

Adverse event: Infusion site pain
Serious: no
Organ System: General disorders
Notes: The Organ System includes "administration site conditions."
Frequency: 1 affected / 14 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 14 at risk
Study: NCT00979901

Adverse event: Pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 352 at risk
Study: NCT00980044

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Occurred in a completer
Frequency: 1 affected / 17 at risk

Adverse event: fleeting chest pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Occurred in a completer
Frequency: 1 affected / 17 at risk

Adverse event: athletes foot
Serious: no
Organ System: Infections and infestations
Notes: Occurred in a non-completer.
Frequency: 1 affected / 17 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Occurred in a completer
Frequency: 1 affected / 19 at risk

Adverse event: left shoulder pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Pre-existing condition -- pain due to old MVA whereby shoulder was hurt. Occurred in a non-completer.
Frequency: 1 affected / 19 at risk

Adverse event: unsteady urine flow without dysuria
Serious: no
Organ System: Renal and urinary disorders
Notes: Occurred in a completer
Frequency: 1 affected / 17 at risk

Adverse event: sore throat/strep B
Serious: no
Organ System: Infections and infestations
Notes: Occurred in a completer
Frequency: 1 affected / 17 at risk

Adverse event: Toothache
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Cracked right front tooth prior to admission to study - now with mild pain in that tooth. Occurred in a non-completer.
Frequency: 1 affected / 17 at risk

Adverse event: Flank pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: right sided flank pain that started 2 days prior to randomization, mild severity, occurs when twisting body. Occurred in a non-completer.
Frequency: 1 affected / 17 at risk

Adverse event: sore throat with cough
Serious: no
Organ System: Infections and infestations
Notes: Occurred in a non-completer.
Frequency: 1 affected / 17 at risk
Study: NCT00980148

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 155 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 155 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 155 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 155 at risk
Study: NCT00980200

Adverse event: Upper respiratory tract information
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 74 at risk

Adverse event: Upper respiratory tract information
Serious: no
Organ System: Infections and infestations
Frequency: 3 affected / 74 at risk

Adverse event: Road traffic accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 73 at risk
Study: NCT00980395

Adverse event: Thrombocytopenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 6 affected / 24 at risk

Adverse event: Neutropenia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 24 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 24 at risk

Adverse event: Dyspnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 24 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 19 affected / 24 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 4 affected / 24 at risk

Adverse event: Neuropathy peripheral
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 24 at risk
Study: NCT00980681

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

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

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

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 10 at risk
Study: NCT00980746

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Acute myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 85 at risk

Adverse event: Cardiac failure congestive
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Ascites
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 85 at risk

Adverse event: Bundle branch block left
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 85 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 85 at risk

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

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 89 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 89 at risk

Adverse event: Loss of consciousness
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 89 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 7 affected / 95 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 95 at risk

Adverse event: Somnolence
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 95 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 95 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 100 at risk

Adverse event: Angina pectoris
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Bradyarrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 100 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 100 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 10 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 100 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 100 at risk

Adverse event: Vertigo
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 6 affected / 100 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 100 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 92 at risk

Adverse event: Nausea
Serious: no
Organ System: General disorders
Frequency: 6 affected / 96 at risk
Study: NCT00980980

Adverse event: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A mild adverse event included any criteria less than moderate
Frequency: 2 affected / 24752 at risk

Adverse event: Mild
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: A mild adverse event included any criteria less than moderate
Frequency: 5 affected / 26024 at risk
Study: NCT00981084

Adverse event: sleep difficulties
Serious: no
Organ System: Nervous system disorders
Notes: participants reported some difficulty falling asleep
Frequency: 1 affected / 17 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 17 at risk

Adverse event: sleep difficulties
Serious: no
Organ System: Nervous system disorders
Notes: participants reported some difficulty falling asleep
Frequency: 2 affected / 16 at risk

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

Adverse event: sleep difficulties
Serious: no
Organ System: Nervous system disorders
Notes: participants reported some difficulty falling asleep
Frequency: 2 affected / 17 at risk

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