Study: NCT01554527

Adverse event: Hospitalization for ashthma
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Post-operative hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Notes: Pre-scheduled hospitalizations or within 48 hours of surgery (prior to randomization in the trial)
Frequency: 4 affected / 69 at risk

Adverse event: ER admission due to panic attack
Serious: yes
Organ System: Psychiatric disorders
Notes: This occurred after signing consent but prior to randomization
Frequency: 1 affected / 69 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 8 affected / 69 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 12 affected / 69 at risk

Adverse event: Asthma Exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 17 affected / 69 at risk

Adverse event: Behavior Issues
Serious: no
Organ System: Social circumstances
Frequency: 11 affected / 69 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 38 affected / 69 at risk

Adverse event: Constipation
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 4 affected / 69 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 69 at risk

Adverse event: Enuresis
Serious: no
Organ System: Renal and urinary disorders
Frequency: 5 affected / 69 at risk

Adverse event: GI Distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 69 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 3 affected / 69 at risk

Adverse event: Life Event or Change
Serious: no
Organ System: Social circumstances
Frequency: 2 affected / 69 at risk

Adverse event: Pink Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 69 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 42 affected / 69 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 14 affected / 69 at risk

Adverse event: Strep Throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 69 at risk

Adverse event: Unrelated Accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 22 affected / 69 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 69 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 1 affected / 69 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 7 affected / 69 at risk

Adverse event: Post-operative hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Notes: Pre-scheduled hospitalizations or within 48 hours of surgery (prior to randomization in the trial)
Frequency: 7 affected / 36 at risk

Adverse event: Hypersensitivity
Serious: no
Organ System: Immune system disorders
Frequency: 5 affected / 36 at risk

Adverse event: Anxiety
Serious: no
Organ System: Psychiatric disorders
Frequency: 8 affected / 36 at risk

Adverse event: Asthma Exacerbation
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Behavior Issues
Serious: no
Organ System: Social circumstances
Frequency: 4 affected / 36 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 16 affected / 36 at risk

Adverse event: Influenza like illness
Serious: no
Organ System: General disorders
Frequency: 3 affected / 36 at risk

Adverse event: GI Distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 36 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 2 affected / 36 at risk

Adverse event: HFMD
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 36 at risk

Adverse event: Life Event or Change
Serious: no
Organ System: Social circumstances
Frequency: 5 affected / 36 at risk

Adverse event: Molluscum contagiosum
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 2 affected / 36 at risk

Adverse event: Pink Eye
Serious: no
Organ System: Eye disorders
Frequency: 2 affected / 36 at risk

Adverse event: Skin irritation
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 12 affected / 36 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 5 affected / 36 at risk

Adverse event: Strep Throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 36 at risk

Adverse event: Unrelated Accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 9 affected / 36 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 6 affected / 36 at risk

Adverse event: Dysphonia
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 3 affected / 36 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 2 affected / 36 at risk

Adverse event: Post-operative hospitalization
Serious: yes
Organ System: Surgical and medical procedures
Notes: Pre-scheduled hospitalizations or within 48 hours of surgery (prior to randomization in the trial)
Frequency: 4 affected / 15 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: General disorders
Frequency: 2 affected / 15 at risk

Adverse event: Ear pain
Serious: no
Organ System: Ear and labyrinth disorders
Frequency: 2 affected / 15 at risk

Adverse event: GI Distress
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 15 at risk

Adverse event: Life Event or Change
Serious: no
Organ System: Social circumstances
Frequency: 1 affected / 15 at risk

Adverse event: Strep Throat
Serious: no
Organ System: Infections and infestations
Frequency: 1 affected / 15 at risk

Adverse event: Unrelated Accident
Serious: no
Organ System: Injury, poisoning and procedural complications
Frequency: 1 affected / 15 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 2 affected / 15 at risk