Study: NCT00584194

Adverse event: Rotator cuff surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Cyst exicision
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 153 at risk

Adverse event: Loss of consciousness during physcial assault
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 153 at risk

Adverse event: Thyroidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Obstructive sleep apnea surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Spinal operation
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Meniscus repair surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Partial sigmoidectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Atrial fibrillation
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Laproscopic surgery for RLQ pain
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Left nephrectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Possibly related
Frequency: 13 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Notes: Probably related
Frequency: 2 affected / 153 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Possibly related
Frequency: 8 affected / 153 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 3 affected / 153 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Possibly related
Frequency: 2 affected / 153 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unlikely related
Frequency: 4 affected / 153 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Possibly related
Frequency: 6 affected / 153 at risk

Adverse event: Malaise
Serious: no
Organ System: General disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related
Frequency: 8 affected / 153 at risk

Adverse event: Myalgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 5 affected / 153 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly related
Frequency: 4 affected / 153 at risk

Adverse event: Congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly related
Frequency: 2 affected / 153 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Possibly related
Frequency: 2 affected / 153 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unlikely related
Frequency: 2 affected / 153 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related
Frequency: 2 affected / 153 at risk

Adverse event: Chills
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 3 affected / 153 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Notes: Possibly related
Frequency: 2 affected / 153 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly related
Frequency: 2 affected / 153 at risk

Adverse event: Sinus congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unlikely related
Frequency: 2 affected / 153 at risk

Adverse event: Stuffy nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Stuffy nose
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: warm
Serious: no
Organ System: General disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Fracture
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Lacerations
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Axillary tenderness
Serious: no
Organ System: General disorders
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Chest pain
Serious: no
Organ System: Cardiac disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Dizziness
Serious: no
Organ System: Nervous system disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Throat irritation
Serious: no
Organ System: Gastrointestinal disorders
Notes: Possibly related
Frequency: 2 affected / 153 at risk

Adverse event: Abdominal cramping
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Swollen neck glands
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Sneezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Admittance
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Concussion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Abdominal pain upper
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Foggy head
Serious: no
Organ System: Nervous system disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Neck swollen
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Bump on right arm
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Respiratory tract congestion
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Feeling faint
Serious: no
Organ System: Nervous system disorders
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Musculoskeletal stiffness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Psychiatric disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Lymphadenopathy
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Tender lymph nodes
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Cardiac disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Flashes of light
Serious: no
Organ System: Nervous system disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: GI problems
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Joint injury
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Absence from work
Serious: no
Organ System: General disorders
Notes: No data
Frequency: 1 affected / 153 at risk

Adverse event: Discomfort
Serious: no
Organ System: General disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Sinus headache
Serious: no
Organ System: Nervous system disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Urination discomfort
Serious: no
Organ System: Renal and urinary disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Ear pressure
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Nail fungus
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Upper eyelid pain to touch
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Upper eyelid itchy
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Upper eyelid swollen
Serious: no
Organ System: Immune system disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Muscle strain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Rotator cuff screw removal
Serious: no
Organ System: Surgical and medical procedures
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Hyperhidrosis
Serious: no
Organ System: General disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Bradycardia
Serious: no
Organ System: Cardiac disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Neck pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Muscle fatigue
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Conjunctivitis
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Migraine
Serious: no
Organ System: Nervous system disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Itchy bumps on arms
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Probably related
Frequency: 1 affected / 153 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Eye trauma
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Abcess
Serious: no
Organ System: Infections and infestations
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Abdomen pain
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Bil umbilial hernias
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Inguinal hernia
Serious: no
Organ System: Gastrointestinal disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Face swelling
Serious: no
Organ System: Immune system disorders
Notes: Unlikely related
Frequency: 1 affected / 153 at risk

Adverse event: Elevated B/P
Serious: no
Organ System: Investigations
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Investigations
Notes: Possibly related
Frequency: 1 affected / 153 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely related
Frequency: 11 affected / 153 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely related
Frequency: 14 affected / 153 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Unrelated
Frequency: 2 affected / 153 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Notes: Definitely related
Frequency: 10 affected / 153 at risk

Adverse event: Induration
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Tender at site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 8 affected / 153 at risk

Adverse event: Contusion
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 6 affected / 153 at risk

Adverse event: Warmth at site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 4 affected / 153 at risk

Adverse event: Tenderness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 3 affected / 153 at risk

Adverse event: Soreness
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 2 affected / 153 at risk

Adverse event: Warm
Serious: no
Organ System: General disorders
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Axillary pain
Serious: no
Organ System: General disorders
Notes: Probably related
Frequency: 1 affected / 153 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Oedema
Serious: no
Organ System: Metabolism and nutrition disorders
Notes: Definitely related
Frequency: 2 affected / 153 at risk

Adverse event: Ecchymosis
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely related
Frequency: 2 affected / 153 at risk

Adverse event: Hot at site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Erythema
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Burning and pinching
Serious: no
Organ System: General disorders
Notes: Unrelated
Frequency: 1 affected / 153 at risk

Adverse event: Tender to touch
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Burning sensation
Serious: no
Organ System: Nervous system disorders
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Pain at site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Notes: Definitely related
Frequency: 1 affected / 153 at risk

Adverse event: Swelling at site
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: Definitely related
Frequency: 1 affected / 153 at risk