TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01384539

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for congestive heart failure, myocardial infarction, stroke, and/or angina
Frequency: 9 affected / 64 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 64 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: Cardiac disorders
Notes: Hospitalization for congestive heart failure, myocardial infarction, stroke, and/or angina
Frequency: 5 affected / 64 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Renal and urinary disorders
Frequency: 4 affected / 64 at risk
Study: NCT01384591

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash after infusion with Definity
Frequency: 1 affected / 2 at risk
Study: NCT01384877

Adverse event: Paraesthesia
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Dysphagia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dyspnoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 32 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 32 at risk

Adverse event: Feet Swollen
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Throbbing sensation from waist down
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Neck Hurts
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Blood urine present
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: above right hip going up back and down leg
Frequency: 1 affected / 32 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Swelling at needle site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk

Adverse event: Dysgeusia
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 32 at risk

Adverse event: Redness at needle site
Serious: no
Organ System: General disorders
Frequency: 1 affected / 32 at risk
Study: NCT01385033

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

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 20 at risk

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

Adverse event: Presyncope
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 20 at risk
Study: NCT01385059

Adverse event: 10002272-Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 4 at risk

Adverse event: 10040741-Sinus bradycardia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 4 at risk

Adverse event: 10020639-Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: 10020647-Hyperkalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: 10020949-Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 4 at risk

Adverse event: 10021018-Hypokalemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: 10021038-Hyponatremia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 4 at risk

Adverse event: 10003988-Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 4 at risk

Adverse event: 10061461-Erectile dysfunction
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 4 at risk

Adverse event: 10011224-Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 4 at risk

Adverse event: 10020772-Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 4 at risk

Adverse event: 10002272-Anemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 7 at risk

Adverse event: 10000081-Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 7 at risk

Adverse event: 10016256-Fatigue
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: 10033371-Pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: 10054482-Neck edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 7 at risk

Adverse event: 10020639-Hyperglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: 10020949-Hypocalcemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 7 at risk

Adverse event: 10021005-Hypoglycemia
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 7 at risk

Adverse event: 10065780-Muscle weakness left-sided
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 7 at risk

Adverse event: 10013573-Dizziness
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 7 at risk

Adverse event: 10036968-Prostatic pain
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 7 at risk

Adverse event: 10020772-Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 7 at risk
Study: NCT01385137

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 117 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 117 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 23 affected / 117 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 117 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 6 affected / 117 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 55 affected / 117 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 11 affected / 117 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 117 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 4 affected / 117 at risk

Adverse event: Abdominal distension
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 124 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 124 at risk

Adverse event: Dyspepsia
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 124 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 124 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 8 affected / 124 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 63 affected / 124 at risk

Adverse event: Joint range of motion decreased
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 15 affected / 124 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 124 at risk

Adverse event: Hot flush
Serious: no
Organ System: Vascular disorders
Frequency: 8 affected / 124 at risk
Study: NCT01385280

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Decreased appetite
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fracture
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Weight decreased
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pleural effusion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT01385306

Adverse event: Hospitalization for respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk

Adverse event: Chest discomfort
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 6 at risk
Study: NCT01385644

Adverse event: Small intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Notes: Patient presented with severe abdominal pain. Analgesia, IV antibiotics and hospital admission. CT Scan confirmed small bowel obstruction. Surgery- Small bowel obstruction secondary to band adhesions. Pt recovered and discharged.
Frequency: 1 affected / 4 at risk

Adverse event: Breath odour
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All pateints experienced halitosis post infusion
Frequency: 4 affected / 4 at risk

Adverse event: Breath odour
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: All pateints experienced halitosis post infusion
Frequency: 4 affected / 4 at risk
Study: NCT01385995

Adverse event: Chest Pain (non cardiac)
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: skin irritation from nasal CPAP mask
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 6 affected / 50 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Eye irritation
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Boil on Lip
Serious: no
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 50 at risk

Adverse event: Skin irritation from echocardiogram leads
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 50 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Notes: While wearing mask
Frequency: 1 affected / 50 at risk

Adverse event: skin irritation from nasal CPAP mask
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 50 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 50 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 50 at risk

Adverse event: Drowsy Driving
Serious: no
Organ System: Social circumstances
Notes: Deemed to be unrelated to study; direct result from sleep deprivation; event last less than 5 seconds.
Frequency: 1 affected / 50 at risk

Adverse event: Claustrophobia
Serious: no
Organ System: Psychiatric disorders
Notes: secondary to mask
Frequency: 1 affected / 50 at risk
Study: NCT01386008

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 3 affected / 20 at risk
Study: NCT01386125

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 375 at risk

Adverse event: Nasal polypectomy
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 1 affected / 375 at risk

Adverse event: Ventricular extrasystoles
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 373 at risk

Adverse event: Fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 373 at risk

Adverse event: Diabetes mellitus
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 373 at risk
Study: NCT01386528

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 13 at risk

Adverse event: Conjunctival haemorrhage
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 13 at risk

Adverse event: Epigastric discomfort
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Skin abrasion
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Face oedema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Fall
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 13 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Hypertension
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 13 at risk

Adverse event: Musculoskeletal discomfort
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Oral mucosal erythema
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pruritus
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 13 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 13 at risk

Adverse event: Serum ferritin increased
Serious: no
Organ System: Investigations
Frequency: 1 affected / 13 at risk

Adverse event: Type 2 diabetes mellitus
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 13 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 13 at risk
Study: NCT01386606

Adverse event: Insomnia
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 16 at risk

Adverse event: Epididymal cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 16 at risk

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

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

Adverse event: Aggression
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Urinary hesitation
Serious: no
Organ System: Renal and urinary disorders
Frequency: 1 affected / 14 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 16 at risk

Adverse event: Vision blurred
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Fluid retention
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 14 at risk

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

Adverse event: Libido increased
Serious: no
Organ System: Psychiatric disorders
Frequency: 1 affected / 14 at risk

Adverse event: Acne
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 14 at risk
Study: NCT01386645

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Notes: Participant did not perform proper food handling and developed food poisoning with acute nausea, vomiting and diarrhea.
Frequency: 1 affected / 18 at risk

Adverse event: cracked tooth
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: Participant reported that he cracked a tooth while eating broccoli that he said had something hard in it.
Frequency: 1 affected / 18 at risk
Study: NCT01386879

Adverse event: post-operative cough, sputum production or wheezing within 24 hours
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-operative cough, sputum production or wheezing within 24 hours
Frequency: 1 affected / 17 at risk

Adverse event: post-operative cough, sputum production or wheezing within 24 hours
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-operative cough, sputum production or wheezing within 24 hours
Frequency: 1 affected / 17 at risk

Adverse event: post-operative cough, sputum production or wheezing within 24 hours
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: post-operative cough, sputum production or wheezing within 24 hours
Frequency: 1 affected / 16 at risk
Study: NCT01386970

Adverse event: Abnormal lab- Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Notes: bilirubin increase
Frequency: 7 affected / 20 at risk

Adverse event: Nausea, Vomiting, and/or Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI distress leading to subject withdrawal
Frequency: 4 affected / 20 at risk

Adverse event: Abnormal lab- Bilirubin
Serious: no
Organ System: Hepatobiliary disorders
Notes: bilirubin increase
Frequency: 8 affected / 23 at risk

Adverse event: Abnormal Lab- albumin
Serious: no
Organ System: Hepatobiliary disorders
Notes: Decrease in albumin
Frequency: 6 affected / 23 at risk

Adverse event: Abnormal Lab- Alanine Aminotransferase (ALT)
Serious: no
Organ System: Hepatobiliary disorders
Notes: increase in Alanine Aminotransferase (ALT)
Frequency: 7 affected / 23 at risk

Adverse event: Abnormal Lab- Aspartate transaminase (AST)
Serious: no
Organ System: Hepatobiliary disorders
Notes: increase in Aspartate transaminase (AST)
Frequency: 7 affected / 23 at risk

Adverse event: Abnormal Lab- Amylase
Serious: no
Organ System: Endocrine disorders
Notes: Increase in amylase
Frequency: 7 affected / 23 at risk

Adverse event: Nausea, Vomiting, and/or Diarrhea
Serious: no
Organ System: Gastrointestinal disorders
Notes: GI distress leading to subject withdrawal
Frequency: 1 affected / 23 at risk
Study: NCT01387074

Adverse event: Status epilepticus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 108 at risk

Adverse event: Bacteraemia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Pneumonia aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 108 at risk

Adverse event: Clostridium difficile colitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 108 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Type 2 diabetes mellitus
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 108 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 108 at risk

Adverse event: Urinary tract candidiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 108 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 108 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 108 at risk
Study: NCT01387139

Adverse event: Respiratory depression
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 99 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 21 affected / 99 at risk

Adverse event: Cardiovascular event
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 99 at risk

Adverse event: Unpleasant recovery Reaction
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 99 at risk

Adverse event: Respiratory depression
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 84 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 18 affected / 84 at risk

Adverse event: Unpleasant recovery Reaction
Serious: no
Organ System: Psychiatric disorders
Frequency: 2 affected / 84 at risk
Study: NCT01387230

Adverse event: Non-cardiac chest pain
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 68 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 68 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 7 affected / 68 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 4 affected / 68 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 68 at risk

Adverse event: Lung neoplasm malignant
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 69 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 5 affected / 69 at risk

Adverse event: Back pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 69 at risk

Adverse event: Coronary artery stenosis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 69 at risk

Adverse event: Chronic obstructive pulmonary disease
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 10 affected / 69 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 69 at risk
Study: NCT01387347

Adverse event: General disorder ocular and administration site conditions AND Instillation site pain,
Serious: no
Organ System: Eye disorders
Notes: stinging post administration study gtts (eye drops)
Frequency: 2 affected / 36 at risk