Study: NCT00332189

Adverse event: Gastrooesophageal reflux disease
Serious: yes
Organ System: Gastrointestinal disorders
Notes: A 15 year old female who had perviously participated in PKU-001, PKU-003, and PKU-004, was taking Ibuprofen in addition to 7.2 mg/kg/day of sapropterin dihydrochloride. It is possible that this combination lead to the event of gastroesophageal reflux
Frequency: 1 affected / 111 at risk

Adverse event: Testicular mass
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: The Investigator assessed this event as not related to study drug. The AE verbatim terms for this subject included, testicular mass, and lymphadenectomy.
Frequency: 1 affected / 111 at risk

Adverse event: Tonsillectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: The Investigator assessed the event as not related to study drug. The AE verbatim term for this subject was tonsilectomy.
Frequency: 1 affected / 111 at risk

Adverse event: Dysmenorrhoea
Serious: yes
Organ System: Reproductive system and breast disorders
Notes: The Investigator assessed the event as not related to study drug. The AE verbatim term for this subject was menorrhagia and dysmenorrhoea.
Frequency: 1 affected / 111 at risk

Adverse event: Road traffic accident
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The Investigator assessed the event as not related to study drug. The AE verbatum terms for this subject included, upper back pain following road traffic accident, and neck pain following road traffic accident.
Frequency: 1 affected / 111 at risk

Adverse event: Hand fracture
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The Investigator assessed this event as not related to study drug. The AE verbatim terms for this subject included, dislocation of left scapulo - humeral, fracture right hand, and fracture 3rd hand metacarpal and 4th basal metacarpal right hand.
Frequency: 1 affected / 111 at risk

Adverse event: Surgery
Serious: yes
Organ System: Surgical and medical procedures
Notes: The Investigator assessed the event as not related to study drug. The AE verbatim term for this subject was incontinence.
Frequency: 1 affected / 111 at risk

Adverse event: Lymphadenectomy
Serious: yes
Organ System: Surgical and medical procedures
Notes: The Investigator assessed this event as not related to study drug. The AE verbatim terms for this subject included, testicular mass, and lymphadenectomy.
Frequency: 1 affected / 111 at risk

Adverse event: Joint dislocation
Serious: yes
Organ System: Injury, poisoning and procedural complications
Notes: The Investigator assessed this event as not related to study drug. The AE verbatim terms for this subject included, dislocation of left scapulo - humeral, fracture right hand, and fracture 3rd hand metacarpal and 4th basal metacarpal right hand.
Frequency: 1 affected / 111 at risk

Adverse event: Bronchitis
Serious: no
Organ System: Infections and infestations
Notes: Events listed in the Other Adverse Events Table include events assessed as related to study drug and events assessed as non-related to study drug.
Frequency: 6 affected / 111 at risk

Adverse event: Cough
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 21 affected / 111 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 10 affected / 111 at risk

Adverse event: Gastroenteritis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 111 at risk

Adverse event: Gastroenteritis viral
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 111 at risk

Adverse event: Headache
Serious: no
Organ System: Nervous system disorders
Frequency: 13 affected / 111 at risk

Adverse event: Influenza
Serious: no
Organ System: Infections and infestations
Frequency: 9 affected / 111 at risk

Adverse event: Nasal congestion
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 9 affected / 111 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 20 affected / 111 at risk

Adverse event: Pharyngitis
Serious: no
Organ System: Infections and infestations
Frequency: 7 affected / 111 at risk

Adverse event: Laryngeal pain
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 10 affected / 111 at risk

Adverse event: Pyrexia
Serious: no
Organ System: General disorders
Frequency: 18 affected / 111 at risk

Adverse event: Rhinorrhoea
Serious: no
Organ System: Respiratory, thoracic and mediastinal disorders
Frequency: 6 affected / 111 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Frequency: 22 affected / 111 at risk

Adverse event: Viral infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 111 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 20 affected / 111 at risk