Study: NCT00914966

Adverse event: Hereditary angioedema
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Laryngeal HAE attack; Not related to study drug
Frequency: 1 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: 83% mild, 17% moderate
Frequency: 3 affected / 20 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: 100% mild
Frequency: 3 affected / 20 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: 100% mild
Frequency: 1 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 100% moderate
Frequency: 1 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 50% mild, 50% severe
Frequency: 2 affected / 20 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 33% mild, 33% moderate, 33% severe
Frequency: 1 affected / 20 at risk

Adverse event: Complication associated with device
Serious: no
Organ System: General disorders
Notes: 100% mild
Frequency: 2 affected / 20 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: 100% moderate
Frequency: 2 affected / 20 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 100% moderate
Frequency: 1 affected / 20 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: 50% mild, 50% moderate
Frequency: 1 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: 100% mild
Frequency: 1 affected / 20 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not related to study drug
Frequency: 1 affected / 13 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not related to study drug
Frequency: 1 affected / 13 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: 83% mild, 17% moderate
Frequency: 4 affected / 13 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 33% mild, 33% moderate, 33% severe
Frequency: 1 affected / 13 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 100% moderate
Frequency: 1 affected / 13 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: 50% mild, 50% moderate
Frequency: 1 affected / 13 at risk

Adverse event: Subdural hygroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related to study drug
Frequency: 1 affected / 12 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: 83% mild, 17% moderate
Frequency: 3 affected / 12 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: 100% mild
Frequency: 1 affected / 12 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 100% moderate
Frequency: 1 affected / 12 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 33% mild, 33% moderate, 33% severe
Frequency: 1 affected / 12 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 100% moderate
Frequency: 1 affected / 12 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: 50% mild, 50% moderate
Frequency: 1 affected / 12 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: 50% mild, 50% moderate
Frequency: 1 affected / 12 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: 100% mild
Frequency: 2 affected / 12 at risk

Adverse event: Anaemia
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: Not related to study drug
Frequency: 1 affected / 20 at risk

Adverse event: Hereditary angioedema
Serious: yes
Organ System: Congenital, familial and genetic disorders
Notes: Laryngeal HAE attack; Not related to study drug
Frequency: 1 affected / 20 at risk

Adverse event: Bile duct stone
Serious: yes
Organ System: Hepatobiliary disorders
Notes: Not related to study drug
Frequency: 1 affected / 20 at risk

Adverse event: Subdural hygroma
Serious: yes
Organ System: Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Notes: Not related to study drug
Frequency: 1 affected / 20 at risk

Adverse event: Upper respiratory tract infection
Serious: no
Organ System: Infections and infestations
Notes: 83% mild, 17% moderate
Frequency: 5 affected / 20 at risk

Adverse event: Nasopharyngitis
Serious: no
Organ System: Infections and infestations
Notes: 100% mild
Frequency: 3 affected / 20 at risk

Adverse event: Abdominal discomfort
Serious: no
Organ System: Gastrointestinal disorders
Notes: 100% mild
Frequency: 2 affected / 20 at risk

Adverse event: Arthralgia
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 100% moderate
Frequency: 2 affected / 20 at risk

Adverse event: Diarrhoea
Serious: no
Organ System: Gastrointestinal disorders
Notes: 50% mild, 50% severe
Frequency: 2 affected / 20 at risk

Adverse event: Ligament sprain
Serious: no
Organ System: Injury, poisoning and procedural complications
Notes: 33% mild, 33% moderate, 33% severe
Frequency: 2 affected / 20 at risk

Adverse event: Complication associated with device
Serious: no
Organ System: General disorders
Notes: 100% mild
Frequency: 2 affected / 20 at risk

Adverse event: Oedema peripheral
Serious: no
Organ System: General disorders
Notes: 100% moderate
Frequency: 2 affected / 20 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Notes: 100% moderate
Frequency: 2 affected / 20 at risk

Adverse event: Rhinitis
Serious: no
Organ System: Infections and infestations
Notes: 50% mild, 50% moderate
Frequency: 2 affected / 20 at risk

Adverse event: Sinusitis
Serious: no
Organ System: Infections and infestations
Notes: 50% mild, 50% moderate
Frequency: 2 affected / 20 at risk

Adverse event: Urinary tract infection
Serious: no
Organ System: Infections and infestations
Notes: 100% mild
Frequency: 2 affected / 20 at risk