Study: NCT01090453

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 238 at risk

Adverse event: Accidental exposure to product by child
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 238 at risk

Adverse event: Dairy intolerance
Serious: yes
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 238 at risk

Adverse event: Crying
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 238 at risk

Adverse event: Gastroenteritis norovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 238 at risk

Adverse event: Head injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 238 at risk

Adverse event: Limb injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 238 at risk

Adverse event: Lymphadenopathy
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 238 at risk

Adverse event: Pharyngitis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 238 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 238 at risk

Adverse event: Sandifer's syndrome
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 238 at risk

Adverse event: Thermal burn
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 238 at risk

Adverse event: Tremor
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 238 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 31 affected / 238 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 238 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 19 affected / 238 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 12 affected / 238 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 10 affected / 238 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 238 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 155 affected / 238 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 171 affected / 238 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 147 affected / 238 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 188 affected / 238 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 208 affected / 238 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 169 affected / 238 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 165 affected / 238 at risk

Adverse event: Concussion
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 3 affected / 242 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Aspiration
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Pneumonia
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Choking
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 242 at risk

Adverse event: Croup infectious
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Gastroenteritis adenovirus
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Osteoarthritis
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 242 at risk

Adverse event: Otitis media
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Pyelonephritis
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Rash
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Tendon rupture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 242 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Urinary tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 242 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 242 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 15 affected / 242 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 14 affected / 242 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 17 affected / 242 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 16 affected / 242 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 242 at risk

Adverse event: Pain
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 181 affected / 241 at risk

Adverse event: Erythema
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 183 affected / 241 at risk

Adverse event: Swelling
Serious: no
Organ System: General disorders
Notes: This solicited local symptom was only collected from subjects with their symptom sheets completed.
Frequency: 163 affected / 241 at risk

Adverse event: Somnolence
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 190 affected / 241 at risk

Adverse event: Irritability
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 207 affected / 241 at risk

Adverse event: Loss of appetite
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 154 affected / 241 at risk

Adverse event: Temperature
Serious: no
Organ System: General disorders
Notes: This solicited general symptom was only collected from subjects with their symptom sheets completed.
Frequency: 167 affected / 241 at risk