Study: NCT01171963

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 74 affected / 1666 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 58 affected / 1666 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 44 affected / 1666 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1666 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 1666 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1666 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1666 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1666 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 5 affected / 1666 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Frequency: 3 affected / 1666 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1666 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Glucose-6-phosphate dehydrogenase deficiency
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 3 affected / 1666 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1666 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Asphyxia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 1666 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Cytomegalovirus infection
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1666 at risk

Adverse event: Dermatitis diaper
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Pneumonia klebsiella
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1666 at risk

Adverse event: Thalassaemia beta
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1666 at risk

Adverse event: Varicella
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1666 at risk

Adverse event: Central nervous system infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Cortical dysplasia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Drowning
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Epilepsy
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Haemorrhage intracranial
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Hepatic function abnormal
Serious: yes
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Hydrocele
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Hydronephrosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Hyponatraemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Infectious mononucleosis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Meningitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Myocarditis
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Pneumonia staphylococcal
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Thalassaemia
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Tracheobronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Ureteric stenosis
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Urticaria
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 2 affected / 1666 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 16 affected / 1666 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 1666 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1666 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1666 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 119 affected / 1666 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 103 affected / 1666 at risk

Adverse event: Cough/runny nose
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 313 affected / 1513 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 127 affected / 1513 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 415 affected / 1513 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 253 affected / 1513 at risk

Adverse event: Fever (GSK scale) (Axillary T >= 37.5°C)
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 83 affected / 1513 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 213 affected / 1513 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 14 affected / 150 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 20 affected / 150 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 13 affected / 150 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 44 affected / 153 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 56 affected / 153 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 43 affected / 153 at risk

Adverse event: Fever - Chinese scale: Axillary T >= 37.1°C
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 302 affected / 1513 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 43 affected / 153 at risk

Adverse event: Fever - Chinese scale: Axillary T >= 37.1°C
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 18 affected / 153 at risk

Adverse event: Bronchitis
Serious: yes
Organ System: Infections and infestations
Frequency: 98 affected / 1667 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 61 affected / 1667 at risk

Adverse event: Enteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 73 affected / 1667 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 14 affected / 1667 at risk

Adverse event: Diarrhoea
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 11 affected / 1667 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 1667 at risk

Adverse event: Hand-foot-and-mouth disease
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1667 at risk

Adverse event: Tracheitis
Serious: yes
Organ System: Infections and infestations
Frequency: 4 affected / 1667 at risk

Adverse event: Tonsillitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1667 at risk

Adverse event: Candida infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1667 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1667 at risk

Adverse event: Gastrointestinal disorder
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1667 at risk

Adverse event: Glucose-6-phosphate dehydrogenase deficiency
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Hypokalaemia
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1667 at risk

Adverse event: Laryngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1667 at risk

Adverse event: Diarrhoea infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1667 at risk

Adverse event: Multiple organ dysfunction syndrome
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1667 at risk

Adverse event: Acidosis
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 2 affected / 1667 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Dermatitis diaper
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Febrile convulsion
Serious: yes
Organ System: Nervous system disorders
Frequency: 2 affected / 1667 at risk

Adverse event: Gastroenteritis bacterial
Serious: yes
Organ System: Infections and infestations
Frequency: 2 affected / 1667 at risk

Adverse event: Heart disease congenital
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1667 at risk

Adverse event: Herpangina
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1667 at risk

Adverse event: Inguinal hernia, obstructive
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Intestinal obstruction
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 1667 at risk

Adverse event: Intussusception
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Ventricular septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 2 affected / 1667 at risk

Adverse event: Acute lymphocytic leukaemia
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1667 at risk

Adverse event: Atrial septal defect
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Bacterial diarrhoea
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1667 at risk

Adverse event: Brain contusion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1667 at risk

Adverse event: Brain herniation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1667 at risk

Adverse event: Cerebral haematoma
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Deficiency anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Dyspepsia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Extrapyramidal disorder
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Food poisoning
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Hernia
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Haemophagocytic lymphohistiocytosis
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Frequency: 1 affected / 1667 at risk

Adverse event: Hydrocephalus
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Inguinal hernia
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Liver function test abnormal
Serious: yes
Organ System: Investigations
Frequency: 1 affected / 1667 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1667 at risk

Adverse event: Lymphadenitis
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Malnutrition
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Patent ductus arteriosus
Serious: yes
Organ System: Congenital, familial and genetic disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Shigella infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1667 at risk

Adverse event: Skull fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 1667 at risk

Adverse event: Subarachnoid haemorrhage
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 3 affected / 1667 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 26 affected / 1667 at risk

Adverse event: Asthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 1667 at risk

Adverse event: Dehydration
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 3 affected / 1667 at risk

Adverse event: Bronchiolitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 1667 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 124 affected / 1667 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 123 affected / 1667 at risk

Adverse event: Cough/runny nose
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 366 affected / 1514 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 123 affected / 1514 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 448 affected / 1514 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 250 affected / 1514 at risk

Adverse event: Fever (GSK scale) (Axillary T >= 37.5°C)
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 104 affected / 1514 at risk

Adverse event: Vomiting
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 232 affected / 1514 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 9 affected / 151 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 13 affected / 151 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 6 affected / 151 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 38 affected / 153 at risk

Adverse event: Irritability/Fussiness
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 52 affected / 153 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 32 affected / 153 at risk

Adverse event: Fever - Chinese scale: Axillary T >= 37.1°C
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented, solely on subjects not part of Sub-cohort 2.
Frequency: 313 affected / 1514 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 38 affected / 153 at risk

Adverse event: Fever - Chinese scale: Axillary T >= 37.1°C
Serious: no
Organ System: General disorders
Notes: The analysis was performed on the Total Vaccinated cohort, which included all subjects with at least one dose of the Rotarix™ vaccine or placebo administration documented only on subjects in sub-cohort 2, for whom results were available.
Frequency: 20 affected / 153 at risk