TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01061333

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

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 16 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 16 at risk

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

Adverse event: Rhinitis allergic
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 16 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 15 at risk

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 15 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 15 at risk
Study: NCT01061567

Adverse event: Cerebral insult
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1814 at risk

Adverse event: Gambling
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1814 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1814 at risk

Adverse event: Cardiac failure
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1814 at risk
Study: NCT01061866

Adverse event: Sedation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: seizures exacerbation
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: sensorial neuropathy
Serious: no
Organ System: Nervous system disorders
Notes: Seven patients were in risk however two participant were affected with less adverse events consisted in sensory neuropathy tested with nerve conduction studies.
Frequency: 1 affected / 7 at risk
Study: NCT01062009

Adverse event: Refractory hypoxemia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: One patient developed refractory hypoxemia and had to be cannulated for extracorporeal membrane oxygenation on study day 6. He recovered and survived
Frequency: 1 affected / 6 at risk
Study: NCT01062061

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 727 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 727 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 727 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 727 at risk

Adverse event: Oliguria
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 727 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 51 affected / 727 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 58 affected / 727 at risk
Study: NCT01062074

Adverse event: Injection-site pain
Serious: no
Organ System: General disorders
Frequency: 330 affected / 3605 at risk
Study: NCT01062126

Adverse event: Lead dislodgement or migration
Serious: yes
Organ System: Product Issues
Frequency: 14 affected / 3389 at risk

Adverse event: Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 6 affected / 3389 at risk

Adverse event: Elevated pacing thresholds
Serious: yes
Organ System: Product Issues
Frequency: 3 affected / 3389 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 3389 at risk

Adverse event: Bleeding/Hematoma
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 3389 at risk

Adverse event: Diaphragmatic/Phrenic Nerve Stimulation
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3389 at risk

Adverse event: Dehisence
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3389 at risk

Adverse event: Lead Malfunction
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3389 at risk

Adverse event: Lead fracture
Serious: yes
Organ System: Product Issues
Frequency: 4 affected / 3389 at risk

Adverse event: Device capturing issue
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3389 at risk

Adverse event: Mid-sternal pain at the location of RA and RV leads
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3389 at risk

Adverse event: Open wound at PG incision site
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3389 at risk

Adverse event: Oversensing
Serious: yes
Organ System: Product Issues
Frequency: 1 affected / 3389 at risk

Adverse event: Pericardial effusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 3389 at risk

Adverse event: Cardiac tamponade
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3389 at risk

Adverse event: Pocket Revision- not Healing
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3389 at risk

Adverse event: Set Screw not secured at Implant
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 3389 at risk

Adverse event: Elevated pacing thresholds
Serious: no
Organ System: Product Issues
Frequency: 6 affected / 3389 at risk

Adverse event: Oversensing
Serious: no
Organ System: Product Issues
Frequency: 3 affected / 3389 at risk

Adverse event: Arrhythmia supraventricular
Serious: no
Organ System: Cardiac disorders
Frequency: 2 affected / 3389 at risk

Adverse event: Inappropriate device interaction
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 3389 at risk

Adverse event: Device capturing issue
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 3389 at risk

Adverse event: Syncope
Serious: no
Organ System: Vascular disorders
Frequency: 2 affected / 3389 at risk

Adverse event: Haematoma
Serious: no
Organ System: Vascular disorders
Frequency: 3 affected / 3389 at risk
Study: NCT01062165

Adverse event: Headache
Serious: no
Organ System: General disorders
Notes: Classified as mild by the investigators. Resolved about 30 minutes after 650 mg of acteminophen was administered. Volunteer had a history of headaches and migraines.
Frequency: 1 affected / 18 at risk

Adverse event: Hot flashes and sweating
Serious: no
Organ System: General disorders
Notes: Symptoms resolved within a few hours without any intervention.
Frequency: 1 affected / 18 at risk
Study: NCT01062230

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

Adverse event: platelets
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Creatinine, Serum
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

Adverse event: Low ANC
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Lymphopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Hypertension
Serious: no
Organ System: Cardiac 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: platelets - Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 6 at risk

Adverse event: Albumin - hypoalbuminemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 6 at risk

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

Adverse event: Haemoglobin
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 6 at risk

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

Adverse event: Weak pulse
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 6 at risk
Study: NCT01062256

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 55 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 55 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: General disorders
Frequency: 1 affected / 55 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 55 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dry mouth
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Dry throat
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 103 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 103 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 107 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 107 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 107 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 107 at risk
Study: NCT01062269

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Loose Stool
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Eructation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Flatulence
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk

Adverse event: Urge to have bowel movement
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 42 at risk
Study: NCT01062763

Adverse event: Serious hyperkalemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Plasma potasium above 5.5 mmol/l
Frequency: 1 affected / 61 at risk
Study: NCT01062971

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: ocular burning
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk

Adverse event: Eye pain
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 56 at risk

Adverse event: ocular burning
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 56 at risk

Adverse event: Conjunctival oedema
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 56 at risk
Study: NCT01063036

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Cataract
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 92 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 92 at risk

Adverse event: Haemorrhoids
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 92 at risk

Adverse event: Hepatocellular carcinoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 2 affected / 92 at risk

Adverse event: Radius fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 92 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 92 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 11 affected / 92 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 8 affected / 92 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 7 affected / 92 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 92 at risk

Adverse event: Asthenia
Serious: no
Organ System: General disorders
Frequency: 6 affected / 92 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 92 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 6 affected / 92 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 92 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 92 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 9 affected / 92 at risk
Study: NCT01063049

Adverse event: post-polypectomy bleed
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 200 at risk
Study: NCT01063153

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 3 affected / 38 at risk

Adverse event: Decreased appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 9 affected / 38 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 2 affected / 38 at risk

Adverse event: Dulled Affect
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 38 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 38 at risk

Adverse event: Headache
Serious: no
Organ System: General disorders
Frequency: 11 affected / 38 at risk

Adverse event: Racing Heart
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 38 at risk

Adverse event: Increased Energy
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Frequency: 3 affected / 38 at risk

Adverse event: Feeling jittery
Serious: no
Organ System: General disorders
Frequency: 4 affected / 38 at risk

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

Adverse event: Tension
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 6 affected / 38 at risk
Study: NCT01063348

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 35 at risk

Adverse event: Dry mouth
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 35 at risk

Adverse event: Dizziness
Serious: no
Organ System: General disorders
Frequency: 1 affected / 35 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 31 at risk
Study: NCT01063595

Adverse event: Anaphylactic shock
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Frequency: 10 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 8 affected / 60 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 60 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 60 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 60 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 60 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Frequency: 9 affected / 60 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 9 affected / 60 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 60 at risk

Adverse event: Paraesthesia oral
Serious: no
Organ System: Nervous system disorders
Frequency: 6 affected / 60 at risk

Adverse event: Vertigo
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 60 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 60 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 60 at risk

Adverse event: Urticaria
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 3 affected / 60 at risk
Study: NCT01063972

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 310 at risk

Adverse event: Oral discomfort
Serious: no
Organ System: Product Issues
Notes: Tingling and blister associated with nicotine gum use
Frequency: 1 affected / 310 at risk

Adverse event: Dizziness
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 310 at risk

Adverse event: Change in affect
Serious: no
Organ System: Product Issues
Frequency: 2 affected / 310 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 310 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 310 at risk

Adverse event: Nausea
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 310 at risk

Adverse event: Local skin reaction
Serious: no
Organ System: Product Issues
Notes: Itching or rash at nicotine patch site
Frequency: 1 affected / 310 at risk

Adverse event: Suicidal ideation
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 296 at risk

Adverse event: Dizziness
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 296 at risk

Adverse event: Change in affect
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 296 at risk

Adverse event: Sleep disorder
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 296 at risk

Adverse event: Headache
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 296 at risk

Adverse event: Nausea
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 296 at risk

Adverse event: Tremors
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 296 at risk

Adverse event: Dizziness
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 296 at risk

Adverse event: Loss of bladder control
Serious: no
Organ System: Renal and urinary disorders
Notes: One time, for a few moments
Frequency: 1 affected / 296 at risk

Adverse event: Constipation
Serious: no
Organ System: Product Issues
Frequency: 1 affected / 296 at risk
Study: NCT01064739

Adverse event: Blood urine present
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk
Study: NCT01064830

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 10 at risk

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

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

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

Adverse event: poison ivy contact dermatitis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 10 at risk

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

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

Adverse event: strept throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 10 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 11 at risk

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

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

Adverse event: ductal breast cancer (Stage 1 )
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 11 at risk

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

Adverse event: Oral herpes
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

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

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

Adverse event: seasonal allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 11 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 11 at risk

Adverse event: surgery for breast cancer
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 11 at risk
Study: NCT01064882

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 34 at risk

Adverse event: Eyelids pruritus
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 34 at risk

Adverse event: Eyelid pain
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 34 at risk

Adverse event: Eyelids pruritus
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 34 at risk
Study: NCT01065506

Adverse event: Vertebrae fractures
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Notes: Not obtained during study sessions; deemed unrelated to study procedures
Frequency: 1 affected / 64 at risk

Adverse event: Malignant melanoma
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 72 at risk