Study: NCT01601847

Adverse event: Asthma or Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 4 affected / 153 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 2 affected / 153 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 8 affected / 153 at risk

Adverse event: Lower Respiratory Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 11 affected / 153 at risk

Adverse event: Pulmonary, not otherwise specified
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This category was coded if the event did not fit in the other pre-specified pulmonary categories for infections, wheezing, or apnea.
Frequency: 3 affected / 153 at risk

Adverse event: ALTE or BRUE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Apparent Life Threatening Event" or "Brief Resolved Unexplained Event." The American Academy of Pediatrics preferred terminology changed during the study.
Frequency: 4 affected / 153 at risk

Adverse event: Diarrhea, non-infectious
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 153 at risk

Adverse event: Vomiting, non-infectious
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 3 affected / 153 at risk

Adverse event: GI, not otherwise specified
Serious: yes
Organ System: Gastrointestinal disorders
Notes: This category was coded if the condition did not fit into the other pre-specified GI categories
Frequency: 7 affected / 153 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 153 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 153 at risk

Adverse event: Gastrointestinal infection
Serious: yes
Organ System: Infections and infestations
Frequency: 1 affected / 153 at risk

Adverse event: Other Infection
Serious: yes
Organ System: Infections and infestations
Notes: This category was coded if the infection was not described by other pre-specified infection categories.
Frequency: 3 affected / 153 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 153 at risk

Adverse event: Seizure
Serious: yes
Organ System: Nervous system disorders
Frequency: 1 affected / 153 at risk

Adverse event: Neurologic, not otherwise specified
Serious: yes
Organ System: Nervous system disorders
Notes: This category was coded if the condition was not described by another pre-existing neurologic category.
Frequency: 1 affected / 153 at risk

Adverse event: Fracture (bone)
Serious: yes
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 153 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 4 affected / 153 at risk

Adverse event: Other (not classified elsewhere)
Serious: yes
Organ System: General disorders
Notes: This category was coded if the important signs or symptoms related to the event were was not otherwise described by other pre-existing categories.
Frequency: 6 affected / 153 at risk

Adverse event: Asthma or Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 38 affected / 153 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 84 affected / 153 at risk

Adverse event: Lower Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 27 affected / 153 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 153 at risk

Adverse event: Diarrhea, non-infectious
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 153 at risk

Adverse event: Vomiting, non-infectious
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 153 at risk

Adverse event: GI, not otherwise specified
Serious: no
Organ System: Gastrointestinal disorders
Notes: This category was coded if the event was not described by the other GI categories.
Frequency: 8 affected / 153 at risk

Adverse event: Elevated alkaline phosphatase
Serious: no
Organ System: Endocrine disorders
Frequency: 13 affected / 153 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 27 affected / 153 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 13 affected / 153 at risk

Adverse event: Infection, not otherwise specified
Serious: no
Organ System: Infections and infestations
Notes: This category was coded if the event was not described by another infection category.
Frequency: 44 affected / 153 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 153 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 36 affected / 153 at risk

Adverse event: Other AE
Serious: no
Organ System: General disorders
Notes: This category was coded if the relevant signs/symptoms of the AE were not otherwise captured by other categories.
Frequency: 19 affected / 153 at risk

Adverse event: Asthma or Wheezing
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 13 affected / 147 at risk

Adverse event: Apnoea
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 147 at risk

Adverse event: Upper respiratory tract infection
Serious: yes
Organ System: Infections and infestations
Frequency: 13 affected / 147 at risk

Adverse event: Lower Respiratory Infection
Serious: yes
Organ System: Infections and infestations
Frequency: 18 affected / 147 at risk

Adverse event: Pulmonary, not otherwise specified
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: This category was coded if the event did not fit in the other pre-specified pulmonary categories for infections, wheezing, or apnea.
Frequency: 5 affected / 147 at risk

Adverse event: ALTE or BRUE
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: "Apparent Life Threatening Event" or "Brief Resolved Unexplained Event." The American Academy of Pediatrics preferred terminology changed during the study.
Frequency: 3 affected / 147 at risk

Adverse event: Constipation
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: Vomiting, non-infectious
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 147 at risk

Adverse event: GI, not otherwise specified
Serious: yes
Organ System: Gastrointestinal disorders
Notes: This category was coded if the condition did not fit into the other pre-specified GI categories
Frequency: 2 affected / 147 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 147 at risk

Adverse event: Hypercalcaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 147 at risk

Adverse event: Other Infection
Serious: yes
Organ System: Infections and infestations
Notes: This category was coded if the infection was not described by other pre-specified infection categories.
Frequency: 7 affected / 147 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Hyperbilirubinaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 147 at risk

Adverse event: Rash
Serious: yes
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 147 at risk

Adverse event: Neurologic, not otherwise specified
Serious: yes
Organ System: Nervous system disorders
Notes: This category was coded if the condition was not described by another pre-existing neurologic category.
Frequency: 1 affected / 147 at risk

Adverse event: Failure to thrive
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 147 at risk

Adverse event: Other (not classified elsewhere)
Serious: yes
Organ System: General disorders
Notes: This category was coded if the important signs or symptoms related to the event were was not otherwise described by other pre-existing categories.
Frequency: 3 affected / 147 at risk

Adverse event: Injury
Serious: yes
Organ System: Injury, poisoning and procedural complications
Frequency: 2 affected / 147 at risk

Adverse event: Vision problem
Serious: yes
Organ System: Eye disorders
Frequency: 1 affected / 147 at risk

Adverse event: Asthma or Wheezing
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 36 affected / 147 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 78 affected / 147 at risk

Adverse event: Lower Respiratory Infection
Serious: no
Organ System: Infections and infestations
Frequency: 23 affected / 147 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 9 affected / 147 at risk

Adverse event: Diarrhea, non-infectious
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 16 affected / 147 at risk

Adverse event: Vomiting, non-infectious
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 19 affected / 147 at risk

Adverse event: GI, not otherwise specified
Serious: no
Organ System: Gastrointestinal disorders
Notes: This category was coded if the event was not described by the other GI categories.
Frequency: 17 affected / 147 at risk

Adverse event: Elevated alkaline phosphatase
Serious: no
Organ System: Endocrine disorders
Frequency: 12 affected / 147 at risk

Adverse event: Hypercalcaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 25 affected / 147 at risk

Adverse event: Gastrointestinal infection
Serious: no
Organ System: Infections and infestations
Frequency: 14 affected / 147 at risk

Adverse event: Infection, not otherwise specified
Serious: no
Organ System: Infections and infestations
Notes: This category was coded if the event was not described by another infection category.
Frequency: 51 affected / 147 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 5 affected / 147 at risk

Adverse event: Rash
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 147 at risk

Adverse event: Other AE
Serious: no
Organ System: General disorders
Notes: This category was coded if the relevant signs/symptoms of the AE were not otherwise captured by other categories.
Frequency: 22 affected / 147 at risk