Study: NCT01906866

Adverse event: Non-serious adverse events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COUGH DYSPNOEA ASTHMA RHINORRHOEA
Frequency: 16 affected / 60 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Nervous system disorders
Notes: SOMNOLENCE HEADACHE
Frequency: 25 affected / 60 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: General disorders
Notes: FATIGUE PYREXIA HANGOVER
Frequency: 23 affected / 60 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Gastrointestinal disorders
Notes: VOMITING DIARRHOEA NAUSEA CONSTIPATION
Frequency: 15 affected / 60 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Psychiatric disorders
Notes: MOOD SWINGS AGITATION ANXIETY AGGRESSION
Frequency: 21 affected / 60 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 3 affected / 60 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Infections and infestations
Notes: UPPER RESPIRATORY TRACT INFECTION INFLUENZA OTITIS MEDIA GASTROENTERITIS NASOPHARYNGITIS SINUSITIS
Frequency: 9 affected / 60 at risk

Adverse event: SAE - Serious adverse event
Serious: yes
Organ System: Infections and infestations
Notes: PNEUMONIA EYE INFECTION OTITIS MEDIA ACUTE
Frequency: 1 affected / 65 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COUGH DYSPNOEA ASTHMA RHINORRHOEA
Frequency: 10 affected / 65 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Nervous system disorders
Notes: SOMNOLENCE HEADACHE
Frequency: 12 affected / 65 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: General disorders
Notes: FATIGUE PYREXIA HANGOVER
Frequency: 19 affected / 65 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Gastrointestinal disorders
Notes: VOMITING DIARRHOEA NAUSEA CONSTIPATION
Frequency: 15 affected / 65 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Psychiatric disorders
Notes: MOOD SWINGS AGITATION ANXIETY AGGRESSION
Frequency: 18 affected / 65 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 3 affected / 65 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Infections and infestations
Notes: UPPER RESPIRATORY TRACT INFECTION INFLUENZA OTITIS MEDIA GASTROENTERITIS NASOPHARYNGITIS SINUSITIS
Frequency: 7 affected / 65 at risk

Adverse event: SAE - Serious adverse event
Serious: yes
Organ System: Infections and infestations
Notes: PNEUMONIA EYE INFECTION OTITIS MEDIA ACUTE
Frequency: 2 affected / 95 at risk

Adverse event: SAE -Serious adverse event
Serious: yes
Organ System: Gastrointestinal disorders
Notes: CONSTIPATION
Frequency: 1 affected / 95 at risk

Adverse event: SAE -Serious adverse event
Serious: yes
Organ System: Psychiatric disorders
Notes: AGGRESSION OPPOSITIONAL DEFIANT DISORDER Abnormal behaviour
Frequency: 3 affected / 95 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: COUGH DYSPNOEA ASTHMA RHINORRHOEA
Frequency: 37 affected / 95 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Nervous system disorders
Notes: SOMNOLENCE HEADACHE
Frequency: 42 affected / 95 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: General disorders
Notes: FATIGUE PYREXIA HANGOVER
Frequency: 39 affected / 95 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Gastrointestinal disorders
Notes: VOMITING DIARRHOEA NAUSEA CONSTIPATION
Frequency: 40 affected / 95 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Psychiatric disorders
Notes: MOOD SWINGS AGITATION ANXIETY AGGRESSION
Frequency: 36 affected / 95 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Rash
Frequency: 10 affected / 95 at risk

Adverse event: Non-serious adverse events
Serious: no
Organ System: Infections and infestations
Notes: UPPER RESPIRATORY TRACT INFECTION INFLUENZA OTITIS MEDIA GASTROENTERITIS NASOPHARYNGITIS SINUSITIS
Frequency: 46 affected / 95 at risk