Study: NCT00095576

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Pyrexia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Chills
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Cholecystitis acute
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Gastroenteritis viral
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1484 at risk

Adverse event: Shunt infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1484 at risk

Adverse event: Staphylococcal abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1484 at risk

Adverse event: Vulval abscess
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1484 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1484 at risk

Adverse event: Overdose
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1484 at risk

Adverse event: Craniocerebral injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1484 at risk

Adverse event: Back pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Musculoskeletal pain
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Intervertebral disc protrusion
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Gastric cancer
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1484 at risk

Adverse event: Headache
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Substance dependence
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Nephrolithiasis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Pleural effusion
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Respiratory distress
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Hypertension
Serious: yes
Organ System: Vascular disorders
Frequency: 1 affected / 1484 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 156 affected / 1484 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 94 affected / 1484 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 170 affected / 1484 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 376 affected / 1484 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 76 affected / 1484 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 317 affected / 1484 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 961 affected / 1484 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 337 affected / 1484 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 271 affected / 1484 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 461 affected / 1484 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 1484 at risk

Adverse event: Congenital cardiovascular anomaly
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1495 at risk

Adverse event: Hypoplastic left heart syndrome
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Drug hypersensitivity
Serious: yes
Organ System: Immune system disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Appendicitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1495 at risk

Adverse event: Pulmonary tuberculosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1495 at risk

Adverse event: Asbestosis
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1495 at risk

Adverse event: Gun shot wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1495 at risk

Adverse event: Stab wound
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1495 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Uterine leiomyoma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1495 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Depression
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Mania
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Substance abuse
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Suicide attempt
Serious: yes
Organ System: Psychiatric disorders
Frequency: 1 affected / 1495 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 148 affected / 1495 at risk

Adverse event: Nausea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 75 affected / 1495 at risk

Adverse event: Fatigue
Serious: no
Organ System: General disorders
Frequency: 120 affected / 1495 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 309 affected / 1495 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Frequency: 23 affected / 1495 at risk

Adverse event: Injection site erythema
Serious: no
Organ System: General disorders
Frequency: 143 affected / 1495 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 475 affected / 1495 at risk

Adverse event: Injection site swelling
Serious: no
Organ System: General disorders
Frequency: 115 affected / 1495 at risk

Adverse event: Injection site pain
Serious: no
Organ System: General disorders
Frequency: 81 affected / 1495 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 394 affected / 1495 at risk

Adverse event: Oropharyngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 83 affected / 1495 at risk