Study: NCT00179777

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 51 affected / 1078 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 35 affected / 1078 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 12 affected / 1078 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 23 affected / 1078 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 12 affected / 1078 at risk

Adverse event: Other Unspecified Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 62 affected / 1078 at risk

Adverse event: Suspected Study Formula Intolerence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 1078 at risk

Adverse event: Asthma, Other Forms of Allergy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 1078 at risk

Adverse event: Malignancy
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 1078 at risk

Adverse event: Accident (Not Requiring Hospitalization)
Serious: yes
Organ System: General disorders
Frequency: 9 affected / 1078 at risk

Adverse event: Accident (Requiring Hospitalization)
Serious: yes
Organ System: General disorders
Frequency: 27 affected / 1078 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Event requiring inpatient hospitalization or prolongation of existing hospitalization
Frequency: 47 affected / 1078 at risk

Adverse event: Life-threatening event
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 1078 at risk

Adverse event: Disability/incapacity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Persistent or significant disability/incapacity
Frequency: 3 affected / 1078 at risk

Adverse event: Other Unspecified Adverse Event
Serious: yes
Organ System: General disorders
Frequency: 190 affected / 1078 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 772 affected / 1078 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 515 affected / 1078 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 91 affected / 1078 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 534 affected / 1078 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 93 affected / 1078 at risk

Adverse event: Other, unspecified infection
Serious: no
Organ System: Infections and infestations
Frequency: 765 affected / 1078 at risk

Adverse event: Suspected Study Formula Intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 56 affected / 1078 at risk

Adverse event: Asthma, other forms of allergy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 359 affected / 1078 at risk

Adverse event: Accident, not requiring hospitalization
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 151 affected / 1078 at risk

Adverse event: Hypoglycemia requiring IV glucose
Serious: no
Organ System: Endocrine disorders
Frequency: 20 affected / 1078 at risk

Adverse event: Other, unspecified adverse event
Serious: no
Organ System: General disorders
Frequency: 804 affected / 1078 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 46 affected / 1081 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 29 affected / 1081 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Renal and urinary disorders
Frequency: 11 affected / 1081 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Ear and labyrinth disorders
Frequency: 27 affected / 1081 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 1081 at risk

Adverse event: Other Unspecified Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 61 affected / 1081 at risk

Adverse event: Suspected Study Formula Intolerence
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 1081 at risk

Adverse event: Asthma, Other Forms of Allergy
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 15 affected / 1081 at risk

Adverse event: Malignancy
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1081 at risk

Adverse event: Accident (Not Requiring Hospitalization)
Serious: yes
Organ System: General disorders
Frequency: 11 affected / 1081 at risk

Adverse event: Accident (Requiring Hospitalization)
Serious: yes
Organ System: General disorders
Frequency: 23 affected / 1081 at risk

Adverse event: Hospitalisation
Serious: yes
Organ System: General disorders
Notes: Event requiring inpatient hospitalization or prolongation of existing hospitalization
Frequency: 52 affected / 1081 at risk

Adverse event: Life-threatening event
Serious: yes
Organ System: General disorders
Frequency: 2 affected / 1081 at risk

Adverse event: Disability/incapacity
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: Persistent or significant disability/incapacity
Frequency: 1 affected / 1081 at risk

Adverse event: Other Unspecified Adverse Event
Serious: yes
Organ System: General disorders
Frequency: 215 affected / 1081 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 754 affected / 1081 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 494 affected / 1081 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Renal and urinary disorders
Frequency: 80 affected / 1081 at risk

Adverse event: Otitis media
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 525 affected / 1081 at risk

Adverse event: Pneumonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 91 affected / 1081 at risk

Adverse event: Other, unspecified infection
Serious: no
Organ System: Infections and infestations
Frequency: 740 affected / 1081 at risk

Adverse event: Suspected Study Formula Intolerance
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 49 affected / 1081 at risk

Adverse event: Asthma, other forms of allergy
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 332 affected / 1081 at risk

Adverse event: Accident, not requiring hospitalization
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 140 affected / 1081 at risk

Adverse event: Hypoglycemia requiring IV glucose
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 1081 at risk

Adverse event: Other, unspecified adverse event
Serious: no
Organ System: General disorders
Frequency: 814 affected / 1081 at risk