Study: NCT02197702

Adverse event: Bronchitis
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: requin hospitalisation
Frequency: 1 affected / 24 at risk

Adverse event: General (SOC)
Serious: no
Organ System: General disorders
Notes: Includes:

FEVER, FATIGUE, PAIN IN BOTH LEGS, PAIN LEFT HAND, TOOTHACHE, SLEEP DISORDER
Frequency: 17 affected / 24 at risk

Adverse event: infections and infestations (SOC)
Serious: no
Organ System: Infections and infestations
Notes: Includes: OTITIS, PNEUMONIA, PHARYNGITIS, GASTROENTERITIS, STREPTOCOCCUS PHARYNGITIS, SINUSITIS, CONJONCTIVITIS etc.
Frequency: 17 affected / 24 at risk

Adverse event: Respiratory (SOC)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes:

BRONCHITIS/BRONCHIOLITIS, COUGH, ADENOID HYPERTROPHY, CHRONIC RHINITIS, SNEEZING
Frequency: 7 affected / 24 at risk

Adverse event: Blood and lymphatic system disorders (SOC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Includes:

HETEROZYGOTIE AC, ANEMIA, EPISTAXIS, SPLENOMEGALY
Frequency: 1 affected / 24 at risk

Adverse event: Ear and labyrinth disorders (SOC)
Serious: no
Organ System: Ear and labyrinth disorders
Notes: Includes:

Otalgia , Ruptured tympanic membrane
Frequency: 2 affected / 24 at risk

Adverse event: Eye disorders (SOC)
Serious: no
Organ System: Eye disorders
Notes: Strabism
Frequency: 1 affected / 24 at risk

Adverse event: Gastrointestinal disorders (SOC)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes:

VOMITING, CONSTIPATION, DIARRHEA, RECTAL PROLAPSUS
Frequency: 8 affected / 24 at risk

Adverse event: Immune system disorders (SOC)
Serious: no
Organ System: Immune system disorders
Notes: Allergy
Frequency: 5 affected / 24 at risk

Adverse event: Investigations (SOC)
Serious: no
Organ System: Investigations
Notes: Includes:

ELEVATED CA:CR RATIO, INCREASE BLOOD PHOSPHORUS, LOW ALP, INCREASE IN BLOOD CALCIUM
Frequency: 9 affected / 24 at risk

Adverse event: Musculoskeletal disorders (SOC)
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: PULLED ELBOW
Frequency: 1 affected / 24 at risk

Adverse event: Nervous system disorder (SOC)
Serious: no
Organ System: Nervous system disorders
Notes: Includes: SEIZURE, PERVASIVE DEVELOPMENT DISORDERS
Frequency: 1 affected / 24 at risk

Adverse event: Skin and subcutaneous tissue disorders (SOC)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes: RASH/ERYTHEMA, ECZEMA, GIANOTTI CROSTI SYNDROME, LÉSIONS
Frequency: 4 affected / 24 at risk

Adverse event: Surgical and medical procedures (SOC)
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes: FACE TRAUMA TEETH EXTRACTION, MYRINGOTOMY AND TUBE PLACEMENT
Frequency: 1 affected / 24 at risk

Adverse event: General (SOC)
Serious: no
Organ System: General disorders
Notes: Includes:

FEVER, FATIGUE, PAIN IN BOTH LEGS, PAIN LEFT HAND, TOOTHACHE, SLEEP DISORDER
Frequency: 13 affected / 23 at risk

Adverse event: infections and infestations (SOC)
Serious: no
Organ System: Infections and infestations
Notes: Includes: OTITIS, PNEUMONIA, PHARYNGITIS, GASTROENTERITIS, STREPTOCOCCUS PHARYNGITIS, SINUSITIS, CONJONCTIVITIS etc.
Frequency: 19 affected / 23 at risk

Adverse event: Respiratory (SOC)
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Includes:

BRONCHITIS/BRONCHIOLITIS, COUGH, ADENOID HYPERTROPHY, CHRONIC RHINITIS, SNEEZING
Frequency: 4 affected / 23 at risk

Adverse event: Blood and lymphatic system disorders (SOC)
Serious: no
Organ System: Blood and lymphatic system disorders
Notes: Includes:

HETEROZYGOTIE AC, ANEMIA, EPISTAXIS, SPLENOMEGALY
Frequency: 3 affected / 23 at risk

Adverse event: Gastrointestinal disorders (SOC)
Serious: no
Organ System: Gastrointestinal disorders
Notes: Includes:

VOMITING, CONSTIPATION, DIARRHEA, RECTAL PROLAPSUS
Frequency: 3 affected / 23 at risk

Adverse event: Immune system disorders (SOC)
Serious: no
Organ System: Immune system disorders
Notes: Allergy
Frequency: 2 affected / 23 at risk

Adverse event: Investigations (SOC)
Serious: no
Organ System: Investigations
Notes: Includes:

ELEVATED CA:CR RATIO, INCREASE BLOOD PHOSPHORUS, LOW ALP, INCREASE IN BLOOD CALCIUM
Frequency: 7 affected / 23 at risk

Adverse event: Nervous system disorder (SOC)
Serious: no
Organ System: Nervous system disorders
Notes: Includes: SEIZURE, PERVASIVE DEVELOPMENT DISORDERS
Frequency: 1 affected / 23 at risk

Adverse event: Reproductive system (SOC)
Serious: no
Organ System: Reproductive system and breast disorders
Notes: PHIMOSIS
Frequency: 1 affected / 23 at risk

Adverse event: Skin and subcutaneous tissue disorders (SOC)
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Notes: Includes: RASH/ERYTHEMA, ECZEMA, GIANOTTI CROSTI SYNDROME, LÉSIONS
Frequency: 7 affected / 23 at risk

Adverse event: Surgical and medical procedures (SOC)
Serious: no
Organ System: Surgical and medical procedures
Notes: Includes: FACE TRAUMA TEETH EXTRACTION, MYRINGOTOMY AND TUBE PLACEMENT
Frequency: 1 affected / 23 at risk